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Code of Federal Regulations

Subpart E

Surgical Devices

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.878.4425Skin patch for treatment of hyperhidrosis.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.878.4675Breast implant suction retrieval system.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.878.4880Phototherapy device for reducing the appearance of acute post-surgical incisions.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.