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Title 21

Displaying title 21, up to date as of 7/09/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 878General and Plastic Surgery Devices878.1 – 878.5910
Subpart ESurgical Devices878.4010 – 878.5050
§ 878.4010Tissue adhesive.
§ 878.4011Tissue adhesive with adjunct wound closure device for topical approximation of skin.
§ 878.4014Nonresorbable gauze/sponge for external use.
§ 878.4015Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
§ 878.4018Hydrophilic wound dressing.
§ 878.4020Occlusive wound dressing.
§ 878.4022Hydrogel wound dressing and burn dressing.
§ 878.4025Silicone sheeting.
§ 878.4040Surgical apparel.
§ 878.4100Organ bag.
§ 878.4160Surgical camera and accessories.
§ 878.4165Wound autofluorescence imaging device.
§ 878.4200Introduction/drainage catheter and accessories.
§ 878.4300Implantable clip.
§ 878.4320Removable skin clip.
§ 878.4340Contact cooling system for aesthetic use.
§ 878.4350Cryosurgical unit and accessories.
§ 878.4360Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
§ 878.4370Surgical drape and drape accessories.
§ 878.4371Irrigating wound retractor device.
§ 878.4380Drape adhesive.
§ 878.4400Electrosurgical cutting and coagulation device and accessories.
§ 878.4410Low energy ultrasound wound cleaner.
§ 878.4420Electrosurgical device for over-the-counter aesthetic use.
§ 878.4425Skin patch for treatment of hyperhidrosis.
§ 878.4430Microneedling device for aesthetic use.
§ 878.4440Eye pad.
§ 878.4450Nonabsorbable gauze for internal use.
§ 878.4452Nonabsorbable expandable hemostatic sponge for temporary internal use.
§ 878.4454Non-absorbable, hemostatic gauze for temporary internal use.
§ 878.4456Hemostatic device for intraluminal gastrointestinal use.
§ 878.4460Non-powdered surgeon's glove.
§ 878.4470Surgeon's gloving cream.
§ 878.4490Absorbable hemostatic agent and dressing.
§ 878.4493Absorbable poly(glycolide/l-lactide) surgical suture.
§ 878.4494Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
§ 878.4495Stainless steel suture.
§ 878.4520Polytetrafluoroethylene injectable.
§ 878.4550Autofluorescence detection device for general surgery and dermatological use.
§ 878.4580Surgical lamp.
§ 878.4590Focused ultrasound stimulator system for aesthetic use.
§ 878.4630Ultraviolet lamp for dermatologic disorders.
§ 878.4635Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
§ 878.4660Skin marker.
§ 878.4670Internal tissue marker.
§ 878.4675Breast implant suction retrieval system.
§ 878.4680Nonpowered, single patient, portable suction apparatus.
§ 878.4683Non-Powered suction apparatus device intended for negative pressure wound therapy.
§ 878.4685Extracorporeal shock wave device for treatment of chronic wounds.
§ 878.4700Surgical microscope and accessories.
§ 878.4730Surgical skin degreaser or adhesive tape solvent.
§ 878.4740Surgical stapler.
§ 878.4750Implantable staple.
§ 878.4755Absorbable lung biopsy plug.
§ 878.4760Removable skin staple.
§ 878.4780Powered suction pump.
§ 878.4783Negative pressure wound therapy device for reduction of wound complications.
§ 878.4790Powered surgical instrument for improvement in the appearance of cellulite.
§ 878.4800Manual surgical instrument for general use.
§ 878.4805Manual percutaneous surgical set assembled in the abdomen.
§ 878.4810Laser surgical instrument for use in general and plastic surgery and in dermatology.
§ 878.4815Magnetic surgical instrument system.
§ 878.4820Surgical instrument motors and accessories/attachments.
§ 878.4825General laparoscopic power morcellation containment system.
§ 878.4830Absorbable surgical gut suture.
§ 878.4840Absorbable polydioxanone surgical suture.
§ 878.4850Blood lancets.
§ 878.4860Light based energy source device for topical application.
§ 878.4880Phototherapy device for reducing the appearance of acute post-surgical incisions.
§ 878.4930Suture retention device.
§ 878.4950Manual operating table and accessories and manual operating chair and accessories.
§ 878.4960Operating tables and accessories and operating chairs and accessories.
§ 878.4961Mountable electromechanical surgical system for transluminal approaches.
§ 878.5000Nonabsorbable poly(ethylene terephthalate) surgical suture.
§ 878.5010Nonabsorbable polypropylene surgical suture.
§ 878.5020Nonabsorbable polyamide surgical suture.
§ 878.5030Natural nonabsorbable silk surgical suture.
§ 878.5035Nonabsorbable expanded polytetrafluoroethylene surgical suture.
§ 878.5040Suction lipoplasty system.
§ 878.5050Surgical smoke precipitator.