Part 878 - GENERAL AND PLASTIC SURGERY DEVICES  


Subpart A — General Provisions
§ 878.1 Scope.
§ 878.3 Effective dates of requirement for premarket approval.
§ 878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B — Diagnostic Devices
§ 878.1800 Speculum and accessories.
Subpart C [Reserved]
Subpart D — Prosthetic Devices
§ 878.3250 External facial fracture fixation appliance.
§ 878.3300 Surgical mesh.
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
§ 878.3530 Silicone inflatable breast prosthesis.
§ 878.3540 Silicone gel-filled breast prosthesis.
§ 878.3550 Chin prosthesis.
§ 878.3590 Ear prosthesis.
§ 878.3610 Esophageal prosthesis.
§ 878.3680 Nose prosthesis.
§ 878.3720 Tracheal prosthesis.
§ 878.3750 External prosthesis adhesive.
§ 878.3800 External aesthetic restoration prosthesis.
§ 878.3900 Inflatable extremity splint.
§ 878.3910 Noninflatable extremity splint.
§ 878.3925 Plastic surgery kit and accessories.
Subpart E — Surgical Devices
§ 878.4010 Tissue adhesive.
§ 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
§ 878.4014 Nonresorbable gauze/sponge for external use.
§ 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
§ 878.4018 Hydrophilic wound dressing.
§ 878.4020 Occlusive wound dressing.
§ 878.4022 Hydrogel wound dressing and burn dressing.
§ 878.4025 Silicone sheeting.
§ 878.4040 Surgical apparel.
§ 878.4100 Organ bag.
§ 878.4160 Surgical camera and accessories.
§ 878.4165 Wound autofluorescence imaging device.
§ 878.4200 Introduction/drainage catheter and accessories.
§ 878.4300 Implantable clip.
§ 878.4320 Removable skin clip.
§ 878.4340 Contact cooling system for aesthetic use.
§ 878.4350 Cryosurgical unit and accessories.
§ 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
§ 878.4370 Surgical drape and drape accessories.
§ 878.4371 Irrigating wound retractor device.
§ 878.4380 Drape adhesive.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
§ 878.4410 Low energy ultrasound wound cleaner.
§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.
§ 878.4430 Microneedling device for aesthetic use.
§ 878.4440 Eye pad.
§ 878.4450 Nonabsorbable gauze for internal use.
§ 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
§ 878.4456 Hemostatic device for intraluminal gastrointestinal use.
§ 878.4460 Non-powdered surgeon's glove.
§ 878.4470 Surgeon's gloving cream.
§ 878.4480 Absorbable powder for lubricating a surgeon's glove.
§ 878.4490 Absorbable hemostatic agent and dressing.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
§ 878.4495 Stainless steel suture.
§ 878.4520 Polytetrafluoroethylene injectable.
§ 878.4580 Surgical lamp.
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
§ 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
§ 878.4660 Skin marker.
§ 878.4670 Internal tissue marker.
§ 878.4680 Nonpowered, single patient, portable suction apparatus.
§ 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
§ 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
§ 878.4700 Surgical microscope and accessories.
§ 878.4730 Surgical skin degreaser or adhesive tape solvent.
§ 878.4750 Implantable staple.
§ 878.4755 Absorbable Lung Biopsy Plug.
§ 878.4760 Removable skin staple.
§ 878.4780 Powered suction pump.
§ 878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
§ 878.4800 Manual surgical instrument for general use.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
§ 878.4815 Magnetic surgical instrument system.
§ 878.4820 Surgical instrument motors and accessories/attachments.
§ 878.4830 Absorbable surgical gut suture.
§ 878.4840 Absorbable polydioxanone surgical suture.
§ 878.4860 Light based energy source device for topical application.
§ 878.4930 Suture retention device.
§ 878.4950 Manual operating table and accessories and manual operating chair and accessories.
§ 878.4960 Operating tables and accessories and operating chairs and accessories.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
§ 878.5020 Nonabsorbable polyamide surgical suture.
§ 878.5030 Natural nonabsorbable silk surgical suture.
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
§ 878.5040 Suction lipoplasty system.
§ 878.5050 Surgical smoke precipitator.
Subpart F — Therapeutic Devices
§ 878.5070 Air-handling apparatus for a surgical operating room.
§ 878.5350 Needle-type epilator.
§ 878.5360 Tweezer-type epilator.
§ 878.5400 Low level laser system for aesthetic use
§ 878.5650 Topical oxygen chamber for extremities.
§ 878.5900 Nonpneumatic tourniquet.
§ 878.5910 Pneumatic tourniquet.

Authority

21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

Source

53 FR 23872, June 24, 1988, unless otherwise noted.

EditorNote

, Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.