Subpart E—Surgical Devices

1. CFR
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3. Title 21
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5. Chapter I
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7. Part 878
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9. Subpart E

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 878.4010
  § 878.4010 Tissue adhesive.
• 878.4011
  § 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
• 878.4014
  § 878.4014 Nonresorbable gauze/sponge for external use.
• 878.4015
  § 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
• 878.4018
  § 878.4018 Hydrophilic wound dressing.
• 878.4020
  § 878.4020 Occlusive wound dressing.
• 878.4022
  § 878.4022 Hydrogel wound dressing and burn dressing.
• 878.4025
  § 878.4025 Silicone sheeting.
• 878.4040
  § 878.4040 Surgical apparel.
• 878.4100
  § 878.4100 Organ bag.
• 878.4160
  § 878.4160 Surgical camera and accessories.
• 878.4165
  § 878.4165 Wound autofluorescence imaging device.
• 878.4200
  § 878.4200 Introduction/drainage catheter and accessories.
• 878.4300
  § 878.4300 Implantable clip.
• 878.4320
  § 878.4320 Removable skin clip.
• 878.4340
  § 878.4340 Contact cooling system for aesthetic use.
• 878.4350
  § 878.4350 Cryosurgical unit and accessories.
• 878.4360
  § 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
• 878.4370
  § 878.4370 Surgical drape and drape accessories.
• 878.4371
  § 878.4371 Irrigating wound retractor device.
• 878.4380
  § 878.4380 Drape adhesive.
• 878.4400
  § 878.4400 Electrosurgical cutting and coagulation device and accessories.
• 878.4410
  § 878.4410 Low energy ultrasound wound cleaner.
• 878.4420
  § 878.4420 Electrosurgical device for over-the-counter aesthetic use.
• 878.4430
  § 878.4430 Microneedling device for aesthetic use.
• 878.4440
  § 878.4440 Eye pad.
• 878.4450
  § 878.4450 Nonabsorbable gauze for internal use.
• 878.4452
  § 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
• 878.4454
  § 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
• 878.4456
  § 878.4456 Hemostatic device for intraluminal gastrointestinal use.
• 878.4460
  § 878.4460 Non-powdered surgeon's glove.
• 878.4470
  § 878.4470 Surgeon's gloving cream.
• 878.4490
  § 878.4490 Absorbable hemostatic agent and dressing.
• 878.4493
  § 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
• 878.4494
  § 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
• 878.4495
  § 878.4495 Stainless steel suture.
• 878.4520
  § 878.4520 Polytetrafluoroethylene injectable.
• 878.4550
  § 878.4550 Autofluorescence detection device for general surgery and dermatological use.
• 878.4580
  § 878.4580 Surgical lamp.
• 878.4590
  § 878.4590 Focused ultrasound stimulator system for aesthetic use.
• 878.4630
  § 878.4630 Ultraviolet lamp for dermatologic disorders.
• 878.4635
  § 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
• 878.4660
  § 878.4660 Skin marker.
• 878.4670
  § 878.4670 Internal tissue marker.
• 878.4680
  § 878.4680 Nonpowered, single patient, portable suction apparatus.
• 878.4683
  § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
• 878.4685
  § 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
• 878.4700
  § 878.4700 Surgical microscope and accessories.
• 878.4730
  § 878.4730 Surgical skin degreaser or adhesive tape solvent.
• 878.4740
  § 878.4740 Surgical stapler.
• 878.4750
  § 878.4750 Implantable staple.
• 878.4755
  § 878.4755 Absorbable lung biopsy plug.
• 878.4760
  § 878.4760 Removable skin staple.
• 878.4780
  § 878.4780 Powered suction pump.
• 878.4783
  § 878.4783 Negative pressure wound therapy device for reduction of wound complications.
• 878.4790
  § 878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
• 878.4800
  § 878.4800 Manual surgical instrument for general use.
• 878.4805
  § 878.4805 Manual percutaneous surgical set assembled in the abdomen.
• 878.4810
  § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
• 878.4815
  § 878.4815 Magnetic surgical instrument system.
• 878.4820
  § 878.4820 Surgical instrument motors and accessories/attachments.
• 878.4825
  § 878.4825 General laparoscopic power morcellation containment system.
• 878.4830
  § 878.4830 Absorbable surgical gut suture.
• 878.4840
  § 878.4840 Absorbable polydioxanone surgical suture.
• 878.4850
  § 878.4850 Blood lancets.
• 878.4860
  § 878.4860 Light based energy source device for topical application.
• 878.4930
  § 878.4930 Suture retention device.
• 878.4950
  § 878.4950 Manual operating table and accessories and manual operating chair and accessories.
• 878.4960
  § 878.4960 Operating tables and accessories and operating chairs and accessories.
• 878.4961
  § 878.4961 Mountable electromechanical surgical system for transluminal approaches.
• 878.5000
  § 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
• 878.5010
  § 878.5010 Nonabsorbable polypropylene surgical suture.
• 878.5020
  § 878.5020 Nonabsorbable polyamide surgical suture.
• 878.5030
  § 878.5030 Natural nonabsorbable silk surgical suture.
• 878.5035
  § 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
• 878.5040
  § 878.5040 Suction lipoplasty system.
• 878.5050
  § 878.5050 Surgical smoke precipitator.