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