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Part 878 - GENERAL AND PLASTIC SURGERY DEVICES

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Details about Part 878

MEDICAL DEVICES - GENERAL AND PLASTIC SURGERY DEVICES

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Part 878 - GENERAL AND PLASTIC SURGERY DEVICES

Description

Official eCFR Link

§878.1 - Scope.

§878.1800 - Speculum and accessories.

§878.3 - Effective dates of requirement for premarket approval.

§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.

§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.

§878.4580 - 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.