21 CFR Subpart E - Subpart E—Surgical Devices

  1. § 878.4010 Tissue adhesive.
  2. § 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
  3. § 878.4014 Nonresorbable gauze/sponge for external use.
  4. § 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
  5. § 878.4018 Hydrophilic wound dressing.
  6. § 878.4020 Occlusive wound dressing.
  7. § 878.4022 Hydrogel wound dressing and burn dressing.
  8. § 878.4025 Silicone sheeting.
  9. § 878.4040 Surgical apparel.
  10. § 878.4100 Organ bag.
  11. § 878.4160 Surgical camera and accessories.
  12. § 878.4165 Wound autofluorescence imaging device.
  13. § 878.4200 Introduction/drainage catheter and accessories.
  14. § 878.4300 Implantable clip.
  15. § 878.4320 Removable skin clip.
  16. § 878.4340 Contact cooling system for aesthetic use.
  17. § 878.4350 Cryosurgical unit and accessories.
  18. § 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
  19. § 878.4370 Surgical drape and drape accessories.
  20. § 878.4371 Irrigating wound retractor device.
  21. § 878.4380 Drape adhesive.
  22. § 878.4400 Electrosurgical cutting and coagulation device and accessories.
  23. § 878.4410 Low energy ultrasound wound cleaner.
  24. § 878.4420 Electrosurgical device for over-the-counter aesthetic use.
  25. § 878.4430 Microneedling device for aesthetic use.
  26. § 878.4440 Eye pad.
  27. § 878.4450 Nonabsorbable gauze for internal use.
  28. § 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
  29. § 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
  30. § 878.4456 Hemostatic device for intraluminal gastrointestinal use.
  31. § 878.4460 Non-powdered surgeon's glove.
  32. § 878.4470 Surgeon's gloving cream.
  33. § 878.4490 Absorbable hemostatic agent and dressing.
  34. § 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
  35. § 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
  36. § 878.4495 Stainless steel suture.
  37. § 878.4520 Polytetrafluoroethylene injectable.
  38. § 878.4550 Autofluorescence detection device for general surgery and dermatological use.
  39. § 878.4580 Surgical lamp.
  40. § 878.4590 Focused ultrasound stimulator system for aesthetic use.
  41. § 878.4630 Ultraviolet lamp for dermatologic disorders.
  42. § 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
  43. § 878.4660 Skin marker.
  44. § 878.4670 Internal tissue marker.
  45. § 878.4680 Nonpowered, single patient, portable suction apparatus.
  46. § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
  47. § 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
  48. § 878.4700 Surgical microscope and accessories.
  49. § 878.4730 Surgical skin degreaser or adhesive tape solvent.
  50. § 878.4740 Surgical stapler.
  51. § 878.4750 Implantable staple.
  52. § 878.4755 Absorbable lung biopsy plug.
  53. § 878.4760 Removable skin staple.
  54. § 878.4780 Powered suction pump.
  55. § 878.4783 Negative pressure wound therapy device for reduction of wound complications.
  56. § 878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
  57. § 878.4800 Manual surgical instrument for general use.
  58. § 878.4805 Manual percutaneous surgical set assembled in the abdomen.
  59. § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
  60. § 878.4815 Magnetic surgical instrument system.
  61. § 878.4820 Surgical instrument motors and accessories/attachments.
  62. § 878.4825 General laparoscopic power morcellation containment system.
  63. § 878.4830 Absorbable surgical gut suture.
  64. § 878.4840 Absorbable polydioxanone surgical suture.
  65. § 878.4850 Blood lancets.
  66. § 878.4860 Light based energy source device for topical application.
  67. § 878.4930 Suture retention device.
  68. § 878.4950 Manual operating table and accessories and manual operating chair and accessories.
  69. § 878.4960 Operating tables and accessories and operating chairs and accessories.
  70. § 878.4961 Mountable electromechanical surgical system for transluminal approaches.
  71. § 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
  72. § 878.5010 Nonabsorbable polypropylene surgical suture.
  73. § 878.5020 Nonabsorbable polyamide surgical suture.
  74. § 878.5030 Natural nonabsorbable silk surgical suture.
  75. § 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
  76. § 878.5040 Suction lipoplasty system.
  77. § 878.5050 Surgical smoke precipitator.