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