Title 21

PART 878

Part 878 - General And Plastic Surgery Devices

PART 878 - GENERAL AND PLASTIC SURGERY DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:53 FR 23872, June 24, 1988, unless otherwise noted. Editorial Note:Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.26.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.26.1.1.1SECTION 878.1
   878.1 Scope.
21:8.0.1.1.26.1.1.2SECTION 878.3
   878.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.26.1.1.3SECTION 878.9
   878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.26.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.26.2.1.1SECTION 878.1800
   878.1800 Speculum and accessories.
21:8.0.1.1.26.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.26.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.26.4.1.1SECTION 878.3250
   878.3250 External facial fracture fixation appliance.
21:8.0.1.1.26.4.1.2SECTION 878.3300
   878.3300 Surgical mesh.
21:8.0.1.1.26.4.1.3SECTION 878.3500
   878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
21:8.0.1.1.26.4.1.4SECTION 878.3530
   878.3530 Silicone inflatable breast prosthesis.
21:8.0.1.1.26.4.1.5SECTION 878.3540
   878.3540 Silicone gel-filled breast prosthesis.
21:8.0.1.1.26.4.1.6SECTION 878.3550
   878.3550 Chin prosthesis.
21:8.0.1.1.26.4.1.7SECTION 878.3590
   878.3590 Ear prosthesis.
21:8.0.1.1.26.4.1.8SECTION 878.3610
   878.3610 Esophageal prosthesis.
21:8.0.1.1.26.4.1.9SECTION 878.3680
   878.3680 Nose prosthesis.
21:8.0.1.1.26.4.1.10SECTION 878.3720
   878.3720 Tracheal prosthesis.
21:8.0.1.1.26.4.1.11SECTION 878.3750
   878.3750 External prosthesis adhesive.
21:8.0.1.1.26.4.1.12SECTION 878.3800
   878.3800 External aesthetic restoration prosthesis.
21:8.0.1.1.26.4.1.13SECTION 878.3900
   878.3900 Inflatable extremity splint.
21:8.0.1.1.26.4.1.14SECTION 878.3910
   878.3910 Noninflatable extremity splint.
21:8.0.1.1.26.4.1.15SECTION 878.3925
   878.3925 Plastic surgery kit and accessories.
21:8.0.1.1.26.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.26.5.1.1SECTION 878.4010
   878.4010 Tissue adhesive.
21:8.0.1.1.26.5.1.2SECTION 878.4011
   878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
21:8.0.1.1.26.5.1.3SECTION 878.4014
   878.4014 Nonresorbable gauze/sponge for external use.
21:8.0.1.1.26.5.1.4SECTION 878.4015
   878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
21:8.0.1.1.26.5.1.5SECTION 878.4018
   878.4018 Hydrophilic wound dressing.
21:8.0.1.1.26.5.1.6SECTION 878.4020
   878.4020 Occlusive wound dressing.
21:8.0.1.1.26.5.1.7SECTION 878.4022
   878.4022 Hydrogel wound dressing and burn dressing.
21:8.0.1.1.26.5.1.8SECTION 878.4025
   878.4025 Silicone sheeting.
21:8.0.1.1.26.5.1.9SECTION 878.4040
   878.4040 Surgical apparel.
21:8.0.1.1.26.5.1.10SECTION 878.4100
   878.4100 Organ bag.
21:8.0.1.1.26.5.1.11SECTION 878.4160
   878.4160 Surgical camera and accessories.
21:8.0.1.1.26.5.1.12SECTION 878.4165
   878.4165 Wound autofluorescence imaging device.
21:8.0.1.1.26.5.1.13SECTION 878.4200
   878.4200 Introduction/drainage catheter and accessories.
21:8.0.1.1.26.5.1.14SECTION 878.4300
   878.4300 Implantable clip.
21:8.0.1.1.26.5.1.15SECTION 878.4320
   878.4320 Removable skin clip.
21:8.0.1.1.26.5.1.16SECTION 878.4340
   878.4340 Contact cooling system for aesthetic use.
21:8.0.1.1.26.5.1.17SECTION 878.4350
   878.4350 Cryosurgical unit and accessories.
21:8.0.1.1.26.5.1.18SECTION 878.4360
   878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
21:8.0.1.1.26.5.1.19SECTION 878.4370
   878.4370 Surgical drape and drape accessories.
21:8.0.1.1.26.5.1.20SECTION 878.4371
   878.4371 Irrigating wound retractor device.
21:8.0.1.1.26.5.1.21SECTION 878.4380
   878.4380 Drape adhesive.
21:8.0.1.1.26.5.1.22SECTION 878.4400
   878.4400 Electrosurgical cutting and coagulation device and accessories.
21:8.0.1.1.26.5.1.23SECTION 878.4410
   878.4410 Low energy ultrasound wound cleaner.
21:8.0.1.1.26.5.1.24SECTION 878.4420
   878.4420 Electrosurgical device for over-the-counter aesthetic use.
21:8.0.1.1.26.5.1.25SECTION 878.4430
   878.4430 Microneedling device for aesthetic use.
21:8.0.1.1.26.5.1.26SECTION 878.4440
   878.4440 Eye pad.
21:8.0.1.1.26.5.1.27SECTION 878.4450
   878.4450 Nonabsorbable gauze for internal use.
21:8.0.1.1.26.5.1.28SECTION 878.4452
   878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
21:8.0.1.1.26.5.1.29SECTION 878.4454
   878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
21:8.0.1.1.26.5.1.30SECTION 878.4456
   878.4456 Hemostatic device for intraluminal gastrointestinal use.
21:8.0.1.1.26.5.1.31SECTION 878.4460
   878.4460 Non-powdered surgeon's glove.
21:8.0.1.1.26.5.1.32SECTION 878.4470
   878.4470 Surgeon's gloving cream.
21:8.0.1.1.26.5.1.33SECTION 878.4490
   878.4490 Absorbable hemostatic agent and dressing.
21:8.0.1.1.26.5.1.34SECTION 878.4493
   878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
21:8.0.1.1.26.5.1.35SECTION 878.4494
   878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
21:8.0.1.1.26.5.1.36SECTION 878.4495
   878.4495 Stainless steel suture.
21:8.0.1.1.26.5.1.37SECTION 878.4520
   878.4520 Polytetrafluoroethylene injectable.
21:8.0.1.1.26.5.1.38SECTION 878.4580
   878.4580 Surgical lamp.
21:8.0.1.1.26.5.1.39SECTION 878.4590
   878.4590 Focused ultrasound stimulator system for aesthetic use.
21:8.0.1.1.26.5.1.40SECTION 878.4630
   878.4630 Ultraviolet lamp for dermatologic disorders.
21:8.0.1.1.26.5.1.41SECTION 878.4635
   878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
21:8.0.1.1.26.5.1.42SECTION 878.4660
   878.4660 Skin marker.
21:8.0.1.1.26.5.1.43SECTION 878.4670
   878.4670 Internal tissue marker.
21:8.0.1.1.26.5.1.44SECTION 878.4680
   878.4680 Nonpowered, single patient, portable suction apparatus.
21:8.0.1.1.26.5.1.45SECTION 878.4683
   878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
21:8.0.1.1.26.5.1.46SECTION 878.4685
   878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
21:8.0.1.1.26.5.1.47SECTION 878.4700
   878.4700 Surgical microscope and accessories.
21:8.0.1.1.26.5.1.48SECTION 878.4730
   878.4730 Surgical skin degreaser or adhesive tape solvent.
21:8.0.1.1.26.5.1.49SECTION 878.4750
   878.4750 Implantable staple.
21:8.0.1.1.26.5.1.50SECTION 878.4755
   878.4755 Absorbable lung biopsy plug.
21:8.0.1.1.26.5.1.51SECTION 878.4760
   878.4760 Removable skin staple.
21:8.0.1.1.26.5.1.52SECTION 878.4780
   878.4780 Powered suction pump.
21:8.0.1.1.26.5.1.53SECTION 878.4790
   878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
21:8.0.1.1.26.5.1.54SECTION 878.4800
   878.4800 Manual surgical instrument for general use.
21:8.0.1.1.26.5.1.55SECTION 878.4810
   878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
21:8.0.1.1.26.5.1.56SECTION 878.4815
   878.4815 Magnetic surgical instrument system.
21:8.0.1.1.26.5.1.57SECTION 878.4820
   878.4820 Surgical instrument motors and accessories/attachments.
21:8.0.1.1.26.5.1.58SECTION 878.4830
   878.4830 Absorbable surgical gut suture.
21:8.0.1.1.26.5.1.59SECTION 878.4840
   878.4840 Absorbable polydioxanone surgical suture.
21:8.0.1.1.26.5.1.60SECTION 878.4860
   878.4860 Light based energy source device for topical application.
21:8.0.1.1.26.5.1.61SECTION 878.4930
   878.4930 Suture retention device.
21:8.0.1.1.26.5.1.62SECTION 878.4950
   878.4950 Manual operating table and accessories and manual operating chair and accessories.
21:8.0.1.1.26.5.1.63SECTION 878.4960
   878.4960 Operating tables and accessories and operating chairs and accessories.
21:8.0.1.1.26.5.1.64SECTION 878.5000
   878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
21:8.0.1.1.26.5.1.65SECTION 878.5010
   878.5010 Nonabsorbable polypropylene surgical suture.
21:8.0.1.1.26.5.1.66SECTION 878.5020
   878.5020 Nonabsorbable polyamide surgical suture.
21:8.0.1.1.26.5.1.67SECTION 878.5030
   878.5030 Natural nonabsorbable silk surgical suture.
21:8.0.1.1.26.5.1.68SECTION 878.5035
   878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
21:8.0.1.1.26.5.1.69SECTION 878.5040
   878.5040 Suction lipoplasty system.
21:8.0.1.1.26.5.1.70SECTION 878.5050
   878.5050 Surgical smoke precipitator.
21:8.0.1.1.26.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.26.6.1.1SECTION 878.5070
   878.5070 Air-handling apparatus for a surgical operating room.
21:8.0.1.1.26.6.1.2SECTION 878.5080
   878.5080 Air-handling apparatus accessory.
21:8.0.1.1.26.6.1.3SECTION 878.5350
   878.5350 Needle-type epilator.
21:8.0.1.1.26.6.1.4SECTION 878.5360
   878.5360 Tweezer-type epilator.
21:8.0.1.1.26.6.1.5SECTION 878.5400
   878.5400 Low level laser system for aesthetic use
21:8.0.1.1.26.6.1.6SECTION 878.5650
   878.5650 Topical oxygen chamber for extremities.
21:8.0.1.1.26.6.1.7SECTION 878.5900
   878.5900 Nonpneumatic tourniquet.
21:8.0.1.1.26.6.1.8SECTION 878.5910
   878.5910 Pneumatic tourniquet.