Federal (United States) · Regulations
Subpart E — Surgical Devices
77 sections
77 sections
- 21 C.F.R. § 878.4010Tissue adhesive.
- 21 C.F.R. § 878.4011Tissue adhesive with adjunct wound closure device for topical approximation of skin.
- 21 C.F.R. § 878.4014Nonresorbable gauze/sponge for external use.
- 21 C.F.R. § 878.4015Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
- 21 C.F.R. § 878.4018Hydrophilic wound dressing.
- 21 C.F.R. § 878.4020Occlusive wound dressing.
- 21 C.F.R. § 878.4022Hydrogel wound dressing and burn dressing.
- 21 C.F.R. § 878.4025Silicone sheeting.
- 21 C.F.R. § 878.4040Surgical apparel.
- 21 C.F.R. § 878.4100Organ bag.
- 21 C.F.R. § 878.4160Surgical camera and accessories.
- 21 C.F.R. § 878.4165Wound autofluorescence imaging device.
- 21 C.F.R. § 878.4200Introduction/drainage catheter and accessories.
- 21 C.F.R. § 878.4300Implantable clip.
- 21 C.F.R. § 878.4320Removable skin clip.
- 21 C.F.R. § 878.4340Contact cooling system for aesthetic use.
- 21 C.F.R. § 878.4350Cryosurgical unit and accessories.
- 21 C.F.R. § 878.4360Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
- 21 C.F.R. § 878.4370Surgical drape and drape accessories.
- 21 C.F.R. § 878.4371Irrigating wound retractor device.
- 21 C.F.R. § 878.4380Drape adhesive.
- 21 C.F.R. § 878.4400Electrosurgical cutting and coagulation device and accessories.
- 21 C.F.R. § 878.4410Low energy ultrasound wound cleaner.
- 21 C.F.R. § 878.4420Electrosurgical device for over-the-counter aesthetic use.
- 21 C.F.R. § 878.4430Microneedling device for aesthetic use.
- 21 C.F.R. § 878.4440Eye pad.
- 21 C.F.R. § 878.4450Nonabsorbable gauze for internal use.
- 21 C.F.R. § 878.4452Nonabsorbable expandable hemostatic sponge for temporary internal use.
- 21 C.F.R. § 878.4454Non-absorbable, hemostatic gauze for temporary internal use.
- 21 C.F.R. § 878.4456Hemostatic device for intraluminal gastrointestinal use.
- 21 C.F.R. § 878.4460Non-powdered surgeon's glove.
- 21 C.F.R. § 878.4470Surgeon's gloving cream.
- 21 C.F.R. § 878.4490Absorbable hemostatic agent and dressing.
- 21 C.F.R. § 878.4493Absorbable poly(glycolide/l-lactide) surgical suture.
- 21 C.F.R. § 878.4494Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
- 21 C.F.R. § 878.4495Stainless steel suture.
- 21 C.F.R. § 878.4520Polytetrafluoroethylene injectable.
- 21 C.F.R. § 878.4550Autofluorescence detection device for general surgery and dermatological use.
- 21 C.F.R. § 878.4580Surgical lamp.
- 21 C.F.R. § 878.4590Focused ultrasound stimulator system for aesthetic use.
- 21 C.F.R. § 878.4630Ultraviolet lamp for dermatologic disorders.
- 21 C.F.R. § 878.4635Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
- 21 C.F.R. § 878.4660Skin marker.
- 21 C.F.R. § 878.4670Internal tissue marker.
- 21 C.F.R. § 878.4680Nonpowered, single patient, portable suction apparatus.
- 21 C.F.R. § 878.4683Non-Powered suction apparatus device intended for negative pressure wound therapy.
- 21 C.F.R. § 878.4685Extracorporeal shock wave device for treatment of chronic wounds.
- 21 C.F.R. § 878.4700Surgical microscope and accessories.
- 21 C.F.R. § 878.4730Surgical skin degreaser or adhesive tape solvent.
- 21 C.F.R. § 878.4740Surgical stapler.
- 21 C.F.R. § 878.4750Implantable staple.
- 21 C.F.R. § 878.4755Absorbable lung biopsy plug.
- 21 C.F.R. § 878.4760Removable skin staple.
- 21 C.F.R. § 878.4780Powered suction pump.
- 21 C.F.R. § 878.4783Negative pressure wound therapy device for reduction of wound complications.
- 21 C.F.R. § 878.4790Powered surgical instrument for improvement in the appearance of cellulite.
- 21 C.F.R. § 878.4800Manual surgical instrument for general use.
- 21 C.F.R. § 878.4805Manual percutaneous surgical set assembled in the abdomen.
- 21 C.F.R. § 878.4810Laser surgical instrument for use in general and plastic surgery and in dermatology.
- 21 C.F.R. § 878.4815Magnetic surgical instrument system.
- 21 C.F.R. § 878.4820Surgical instrument motors and accessories/attachments.
- 21 C.F.R. § 878.4825General laparoscopic power morcellation containment system.
- 21 C.F.R. § 878.4830Absorbable surgical gut suture.
- 21 C.F.R. § 878.4840Absorbable polydioxanone surgical suture.
- 21 C.F.R. § 878.4850Blood lancets.
- 21 C.F.R. § 878.4860Light based energy source device for topical application.
- 21 C.F.R. § 878.4930Suture retention device.
- 21 C.F.R. § 878.4950Manual operating table and accessories and manual operating chair and accessories.
- 21 C.F.R. § 878.4960Operating tables and accessories and operating chairs and accessories.
- 21 C.F.R. § 878.4961Mountable electromechanical surgical system for transluminal approaches.
- 21 C.F.R. § 878.5000Nonabsorbable poly(ethylene terephthalate) surgical suture.
- 21 C.F.R. § 878.5010Nonabsorbable polypropylene surgical suture.
- 21 C.F.R. § 878.5020Nonabsorbable polyamide surgical suture.
- 21 C.F.R. § 878.5030Natural nonabsorbable silk surgical suture.
- 21 C.F.R. § 878.5035Nonabsorbable expanded polytetrafluoroethylene surgical suture.
- 21 C.F.R. § 878.5040Suction lipoplasty system.
- 21 C.F.R. § 878.5050Surgical smoke precipitator.