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e-CFR data is current as of October 16, 2020

Title 21Chapter ISubchapter HPart 882 → Subpart E


Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES


Subpart E—Neurological Surgical Devices


Contents
§882.4030   Skull plate anvil.
§882.4060   Ventricular cannula.
§882.4100   Ventricular catheter.
§882.4125   Neurosurgical chair.
§882.4150   Scalp clip.
§882.4175   Aneurysm clip applier.
§882.4190   Clip forming/cutting instrument.
§882.4200   Clip removal instrument.
§882.4215   Clip rack.
§882.4250   Cryogenic surgical device.
§882.4275   Dowel cutting instrument.
§882.4300   Manual cranial drills, burrs, trephines, and their accessories
§882.4305   Powered compound cranial drills, burrs, trephines, and their accessories.
§882.4310   Powered simple cranial drills, burrs, trephines, and their accessories.
§882.4325   Cranial drill handpiece (brace).
§882.4360   Electric cranial drill motor.
§882.4370   Pneumatic cranial drill motor.
§882.4400   Radiofrequency lesion generator.
§882.4440   Neurosurgical headrests.
§882.4460   Neurosurgical head holder (skull clamp).
§882.4500   Cranioplasty material forming instrument.
§882.4525   Microsurgical instrument.
§882.4535   Nonpowered neurosurgical instrument.
§882.4545   Shunt system implantation instrument.
§882.4560   Stereotaxic instrument.
§882.4600   Leukotome.
§882.4650   Neurosurgical suture needle.
§882.4700   Neurosurgical paddie.
§882.4725   Radiofrequency lesion probe.
§882.4750   Skull punch.
§882.4800   Self-retaining retractor for neurosurgery.
§882.4840   Manual rongeur.
§882.4845   Powered rongeur.
§882.4900   Skullplate screwdriver.

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§882.4030   Skull plate anvil.

(a) Identification. A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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§882.4060   Ventricular cannula.

(a) Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019]

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§882.4100   Ventricular catheter.

(a) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.

(b) Classification. Class II (performance standards).

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§882.4125   Neurosurgical chair.

(a) Identification. A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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§882.4150   Scalp clip.

(a) Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.

(b) Classification. Class II (performance standards).

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§882.4175   Aneurysm clip applier.

(a) Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.

(b) Classification. Class II (performance standards).

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§882.4190   Clip forming/cutting instrument.

(a) Identification. A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994]

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§882.4200   Clip removal instrument.

(a) Identification. A clip removal instrument is a device used to remove surgical clips from the patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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§882.4215   Clip rack.

(a) Identification. A clip rack is a device used to hold or store surgical clips during surgery.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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§882.4250   Cryogenic surgical device.

(a) Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.

(b) Classification. Class II (performance standards).

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§882.4275   Dowel cutting instrument.

(a) Identification. A dowel cutting instrument is a device used to cut dowels of bone for bone grafting.

(b) Classification. Class II (performance standards).

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§882.4300   Manual cranial drills, burrs, trephines, and their accessories

(a) Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

(b) Classification. Class II (performance standards).

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§882.4305   Powered compound cranial drills, burrs, trephines, and their accessories.

(a) Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.

(b) Classification. Class II (performance standards).

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§882.4310   Powered simple cranial drills, burrs, trephines, and their accessories.

(a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

(b) Classification. Class II (performance standards).

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§882.4325   Cranial drill handpiece (brace).

(a) Identification. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001]

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§882.4360   Electric cranial drill motor.

(a) Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

(b) Classification. Class II (performance standards).

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§882.4370   Pneumatic cranial drill motor.

(a) Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

(b) Classification. Class II (performance standards).

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§882.4400   Radiofrequency lesion generator.

(a) Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

(b) Classification. Class II (performance standards).

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§882.4440   Neurosurgical headrests.

(a) Identification. A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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§882.4460   Neurosurgical head holder (skull clamp).

(a) Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

(b) Classification. Class II (performance standards).

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§882.4500   Cranioplasty material forming instrument.

(a) Identification. A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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§882.4525   Microsurgical instrument.

(a) Identification. A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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§882.4535   Nonpowered neurosurgical instrument.

(a) Identification. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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§882.4545   Shunt system implantation instrument.

(a) Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019]

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§882.4560   Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).

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§882.4600   Leukotome.

(a) Identification. A leukotome is a device used to cut sections out of the brain.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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§882.4650   Neurosurgical suture needle.

(a) Identification. A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]

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§882.4700   Neurosurgical paddie.

(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

(b) Classification. Class II (performance standards).

[44 FR 51730, Sept. 4, 1979, as amended at 69 FR 10332, Mar. 5, 2004]

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§882.4725   Radiofrequency lesion probe.

(a) Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

(b) Classification. Class II (performance standards).

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§882.4750   Skull punch.

(a) Identification. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under §882.4305.

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]

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§882.4800   Self-retaining retractor for neurosurgery.

(a) Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

(b) Classification. Class II (performance standards).

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§882.4840   Manual rongeur.

(a) Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

(b) Classification. Class II (performance standards).

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§882.4845   Powered rongeur.

(a) Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.

(b) Classification. Class II (performance standards).

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§882.4900   Skullplate screwdriver.

(a) Identification. A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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