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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 878 - General and Plastic Surgery Devices |
| Subpart A - General Provisions |
| § 878.1 - Scope. |
| § 878.3 - Effective dates of requirement for premarket approval. |
| § 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
| Subpart B - Diagnostic Devices |
| § 878.1800 - Speculum and accessories. |
| Subpart C - XXX |
| Subpart D - Prosthetic Devices |
| § 878.3250 - External facial fracture fixation appliance. |
| § 878.3300 - Surgical mesh. |
| § 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material. |
| § 878.3510 - Carbon dioxide gas controlled tissue expander. |
| § 878.3530 - Silicone inflatable breast prosthesis. |
| § 878.3540 - Silicone gel-filled breast prosthesis. |
| § 878.3550 - Chin prosthesis. |
| § 878.3590 - Ear prosthesis. |
| § 878.3610 - Esophageal prosthesis. |
| § 878.3680 - Nose prosthesis. |
| § 878.3720 - Tracheal prosthesis. |
| § 878.3750 - External prosthesis adhesive. |
| § 878.3800 - External aesthetic restoration prosthesis. |
| § 878.3900 - Inflatable extremity splint. |
| § 878.3910 - Noninflatable extremity splint. |
| § 878.3925 - Plastic surgery kit and accessories. |
| Subpart E - Surgical Devices |
| § 878.4010 - Tissue adhesive. |
| § 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. |
| § 878.4025 - Silicone sheeting. |
| § 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. |
| § 878.4450 - 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. |
| § 878.4480 - Absorbable powder for lubricating a surgeon's glove. |
| § 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. |
| § 878.4550 - Autofluorescence detection device for general surgery and dermatological use. |
| § 878.4580 - Surgical lamp. |
| § 878.4590 - Focused ultrasound stimulator system for aesthetic use. |
| § 878.4630 - Ultraviolet lamp for dermatologic disorders. |
| § 878.4635 - Sunlamp products and ultraviolet lamps intended for use in sunlamp products. |
| § 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. |
| § 878.4740 - Surgical stapler. |
| § 878.4750 - Implantable staple. |
| § 878.4755 - Absorbable lung biopsy plug. |
| § 878.4760 - Removable skin staple. |
| § 878.4780 - Powered suction pump. |
| § 878.4783 - Negative pressure wound therapy device for reduction of wound complications. |
| § 878.4790 - Powered surgical instrument for improvement in the appearance of cellulite. |
| § 878.4800 - Manual surgical instrument for general use. |
| § 878.4805 - Manual percutaneous surgical set assembled in the abdomen. |
| § 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. |
| § 878.4825 - General laparoscopic power morcellation containment system. |
| § 878.4830 - Absorbable surgical gut suture. |
| § 878.4840 - Absorbable polydioxanone surgical suture. |
| § 878.4850 - Blood lancets. |
| § 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. |
| § 878.4961 - Mountable electromechanical surgical system for transluminal approaches. |
| § 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. |
| Subpart F - Therapeutic Devices |
| § 878.5070 - Air-handling apparatus for a surgical operating room. |
| § 878.5080 - xxx |
| § 878.5350 - Needle-type epilator. |
| § 878.5360 - Tweezer-type epilator. |
| § 878.5400 - Low level laser system for aesthetic use |
| § 878.5650 - Topical oxygen chamber for extremities. |
| § 878.5900 - Nonpneumatic tourniquet. |
| § 878.5910 - Pneumatic tourniquet. |