21 CFR Part 878 — General and Plastic Surgery Devices
Subpart A — General Provisions
Subpart B — Diagnostic Devices
Subpart D — Prosthetic Devices
- § 878.3250— External facial fracture fixation appliance.
- § 878.3300— Surgical mesh.
- § 878.3500— Polytetrafluoroethylene with carbon fibers composite implant material.
- § 878.3510— Carbon dioxide gas controlled tissue expander.
- § 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.
- § 878.4490— 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.
- § 878.4550— Autofluorescence detection device for general surgery and dermatological use.
- § 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.
- § 878.4740— Surgical stapler.
- § 878.4750— Implantable staple.
- § 878.4755— Absorbable lung biopsy plug.
- § 878.4760— Removable skin staple.
- § 878.4780— Powered suction pump.
- § 878.4783— Negative pressure wound therapy device for reduction of wound complications.
- § 878.4790— Powered surgical instrument for improvement in the appearance of cellulite.
- § 878.4800— Manual surgical instrument for general use.
- § 878.4805— Manual percutaneous surgical set assembled in the abdomen.
- § 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.
- § 878.4825— General laparoscopic power morcellation containment system.
- § 878.4830— Absorbable surgical gut suture.
- § 878.4840— Absorbable polydioxanone surgical suture.
- § 878.4850— Blood lancets.
- § 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.
- § 878.4961— Mountable electromechanical surgical system for transluminal approaches.
- § 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.
- § 878.5080— Air-handling apparatus accessory.
- § 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.