21 CFR Subpart E
Surgical Devices
June 25, 2020
§
878.4635
Sunlamp products and ultraviolet lamps intended for use in sunlamp products
§
878.4010
Tissue adhesive
§
878.4025
Silicone sheeting
§
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
§
878.4040
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
§
878.4630
Ultraviolet lamp for dermatologic disorders
§
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
§
878.4660
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
§
878.4860
Light based energy source device for topical application
§
878.4930
Suture retention device
§
878.4950
Manual operating table and accessories and manual operating chair and accessories
§
878.4960
Operating tables and accessories and operating chairs and accessories
§
878.5000
Nonabsorbable poly(ethylene terephthalate) surgical suture
§
878.5010
Nonabsorbable polypropylene surgical suture
§
878.5020
Nonabsorbable polyamide surgical suture
§
878.5030
Natural nonabsorbable silk surgical suture
§
878.5035
Nonabsorbable expanded polytetrafluoroethylene surgical suture
§
878.5040
Suction lipoplasty system
§
878.5050
Surgical smoke precipitator
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