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Electronic Code of Federal Regulations

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e-CFR Data is current as of August 25, 2014

Title 21Chapter ISubchapter HPart 876


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 876—GASTROENTEROLOGY-UROLOGY DEVICES

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Subpart A—GENERAL PROVISIONS

§876.1
Scope.
§876.3
Effective dates of requirement for premarket approval.
§876.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B—DIAGNOSTIC DEVICES

§876.1075
Gastroenterology-urology biopsy instrument.
§876.1300
Ingestible telemetric gastrointestinal capsule imaging system.
§876.1330
Colon capsule endoscopy system.
§876.1400
Stomach pH electrode.
§876.1500
Endoscope and accessories.
§876.1620
Urodynamics measurement system.
§876.1725
Gastrointestinal motility monitoring system.
§876.1735
Electrogastrography system.
§876.1800
Urine flow or volume measuring system.
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Subpart C—MONITORING DEVICES

§876.2040
Enuresis alarm.
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Subpart D—PROSTHETIC DEVICES

§876.3350
Penile inflatable implant.
§876.3630
Penile rigidity implant.
§876.3750
Testicular prosthesis.
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Subpart E—SURGICAL DEVICES

§876.4020
Fiberoptic light ureteral catheter.
§876.4270
Colostomy rod.
§876.4300
Endoscopic electrosurgical unit and accessories.
§876.4370
Gastroenterology-urology evacuator.
§876.4400
Hemorrhoidal ligator.
§876.4480
Electrohydraulic lithotriptor.
§876.4500
Mechanical lithotriptor.
§876.4530
Gastroenterology-urology fiberoptic retractor.
§876.4560
Ribdam.
§876.4590
Interlocking urethral sound.
§876.4620
Ureteral stent.
§876.4650
Water jet renal stone dislodger system.
§876.4680
Ureteral stone dislodger.
§876.4730
Manual gastroenterology-urology surgical instrument and accessories.
§876.4770
Urethrotome.
§876.4890
Urological table and accessories.
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Subpart F—THERAPEUTIC DEVICES

§876.5010
Biliary catheter and accessories.
§876.5015
Pancreatic drainage stent and delivery system.
§876.5020
External penile rigidity devices.
§876.5030
Continent ileostomy catheter.
§876.5090
Suprapubic urological catheter and accessories.
§876.5130
Urological catheter and accessories.
§876.5160
Urological clamp for males.
§876.5210
Enema kit.
§876.5220
Colonic irrigation system.
§876.5250
Urine collector and accessories.
§876.5270
Implanted electrical urinary continence device.
§876.5280
Implanted mechanical/hydraulic urinary continence device.
§876.5310
Nonimplanted, peripheral electrical continence device.
§876.5320
Nonimplanted electrical continence device.
§876.5365
Esophageal dilator.
§876.5450
Rectal dilator.
§876.5470
Ureteral dilator.
§876.5520
Urethral dilator.
§876.5530
Implantable transprostatic tissue retractor system.
§876.5540
Blood access device and accessories.
§876.5600
Sorbent regenerated dialysate delivery system for hemodialysis.
§876.5630
Peritoneal dialysis system and accessories.
§876.5665
Water purification system for hemodialysis.
§876.5820
Hemodialysis system and accessories.
§876.5830
Hemodialyzer with disposable insert (Kiil type).
§876.5860
High permeability hemodialysis system.
§876.5870
Sorbent hemoperfusion system.
§876.5880
Isolated kidney perfusion and transport system and accessories.
§876.5885
Tissue culture media for human ex vivo tissue and cell culture processing applications.
§876.5895
Ostomy irrigator.
§876.5900
Ostomy pouch and accessories.
§876.5920
Protective garment for incontinence.
§876.5955
Peritoneo-venous shunt.
§876.5970
Hernia support.
§876.5980
Gastrointestinal tube and accessories.
§876.5990
Extracorporeal shock wave lithotripter.


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