Title 21, Part 878 — General and Plastic Surgery Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Speculum and accessories.

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External facial fracture fixation appliance.

Surgical mesh.

Polytetrafluoroethylene with carbon fibers composite implant material.

Carbon dioxide gas controlled tissue expander.

Silicone inflatable breast prosthesis.

Silicone gel-filled breast prosthesis.

Chin prosthesis.

Ear prosthesis.

Esophageal prosthesis.

Nose prosthesis.

Tracheal prosthesis.

External prosthesis adhesive.

External aesthetic restoration prosthesis.

Inflatable extremity splint.

Noninflatable extremity splint.

Plastic surgery kit and accessories.

Tissue adhesive.

Tissue adhesive with adjunct wound closure device for topical approximation of skin.

Nonresorbable gauze/sponge for external use.

Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.

Hydrophilic wound dressing.

Occlusive wound dressing.

Hydrogel wound dressing and burn dressing.

Silicone sheeting.

Surgical apparel.

Organ bag.

Surgical camera and accessories.

Wound autofluorescence imaging device.

Introduction/drainage catheter and accessories.

Implantable clip.

Removable skin clip.

Contact cooling system for aesthetic use.

Cryosurgical unit and accessories.

Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.

Surgical drape and drape accessories.

Irrigating wound retractor device.

Drape adhesive.

Electrosurgical cutting and coagulation device and accessories.

Low energy ultrasound wound cleaner.

Electrosurgical device for over-the-counter aesthetic use.

Microneedling device for aesthetic use.

Eye pad.

Nonabsorbable gauze for internal use.

Nonabsorbable expandable hemostatic sponge for temporary internal use.

Non-absorbable, hemostatic gauze for temporary internal use.

Hemostatic device for intraluminal gastrointestinal use.

Non-powdered surgeon's glove.

Surgeon's gloving cream.

Absorbable hemostatic agent and dressing.

Absorbable poly(glycolide/l-lactide) surgical suture.

Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.

Stainless steel suture.

Polytetrafluoroethylene injectable.

Autofluorescence detection device for general surgery and dermatological use.

Surgical lamp.

Focused ultrasound stimulator system for aesthetic use.

Ultraviolet lamp for dermatologic disorders.

Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

Skin marker.

Internal tissue marker.

Nonpowered, single patient, portable suction apparatus.

Non-Powered suction apparatus device intended for negative pressure wound therapy.

Extracorporeal shock wave device for treatment of chronic wounds.

Surgical microscope and accessories.

Surgical skin degreaser or adhesive tape solvent.

Surgical stapler.

Implantable staple.

Absorbable lung biopsy plug.

Removable skin staple.

Powered suction pump.

Negative pressure wound therapy device for reduction of wound complications.

Powered surgical instrument for improvement in the appearance of cellulite.

Manual surgical instrument for general use.

Manual percutaneous surgical set assembled in the abdomen.

Laser surgical instrument for use in general and plastic surgery and in dermatology.

Magnetic surgical instrument system.

Surgical instrument motors and accessories/attachments.

General laparoscopic power morcellation containment system.

Absorbable surgical gut suture.

Absorbable polydioxanone surgical suture.

Blood lancets.

Light based energy source device for topical application.

Suture retention device.

Manual operating table and accessories and manual operating chair and accessories.

Operating tables and accessories and operating chairs and accessories.

Mountable electromechanical surgical system for transluminal approaches.

Nonabsorbable poly(ethylene terephthalate) surgical suture.

Nonabsorbable polypropylene surgical suture.

Nonabsorbable polyamide surgical suture.

Natural nonabsorbable silk surgical suture.

Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Suction lipoplasty system.

Surgical smoke precipitator.

Air-handling apparatus for a surgical operating room.

Air-handling apparatus accessory.

Needle-type epilator.

Tweezer-type epilator.

Low level laser system for aesthetic use

Topical oxygen chamber for extremities.

Nonpneumatic tourniquet.

Pneumatic tourniquet.