Home/CFR/Title 21/Part 878
FEDERAL · 21 CFR

Part 878 — General and Plastic Surgery Devices

106 sections · Title 21: Food and Drugs

§ 878.1Scope.
§ 878.3Effective dates of requirement for premarket approval.
§ 878.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 878.1800Speculum and accessories.
§ 878.1820xxx
§ 878.3250External facial fracture fixation appliance.
§ 878.3300Surgical mesh.
§ 878.3500Polytetrafluoroethylene with carbon fibers composite implant material.
§ 878.3510Carbon dioxide gas controlled tissue expander.
§ 878.3530Silicone inflatable breast prosthesis.
§ 878.3540Silicone gel-filled breast prosthesis.
§ 878.3550Chin prosthesis.
§ 878.3590Ear prosthesis.
§ 878.3610Esophageal prosthesis.
§ 878.3680Nose prosthesis.
§ 878.3720Tracheal prosthesis.
§ 878.3750External prosthesis adhesive.
§ 878.3800External aesthetic restoration prosthesis.
§ 878.3900Inflatable extremity splint.
§ 878.3910Noninflatable extremity splint.
§ 878.3925Plastic surgery kit and accessories.
§ 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.
§ 878.4430Microneedling 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.
§ 878.4680Nonpowered, 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.
§ 878.4930Suture 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.
§ 878.5070Air-handling apparatus for a surgical operating room.
§ 878.5080Air-handling apparatus accessory.
§ 878.5350Needle-type epilator.
§ 878.5360Tweezer-type epilator.
§ 878.5400Low level laser system for aesthetic use
§ 878.5650Topical oxygen chamber for extremities.
§ 878.5900Nonpneumatic tourniquet.
§ 878.5910Pneumatic tourniquet.