21 CFR Subpart F - Subpart F—Therapeutic Devices

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  1. § 876.5010 Biliary catheter and accessories.
  2. § 876.5011 Metallic biliary stent system for benign strictures.
  3. § 876.5012 Biliary stent, drain, and dilator accessories.
  4. § 876.5015 Pancreatic drainage stent and delivery system.
  5. § 876.5020 External penile rigidity devices.
  6. § 876.5025 Vibrator for climax control of premature ejaculation.
  7. § 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation.
  8. § 876.5030 Continent ileostomy catheter.
  9. § 876.5090 Suprapubic urological catheter and accessories.
  10. § 876.5100 Suprapubic catheter accessories.
  11. § 876.5130 Urological catheter and accessories.
  12. § 876.5140 Urethral insert with pump for bladder drainage.
  13. § 876.5160 Urological clamp.
  14. § 876.5210 Enema kit.
  15. § 876.5220 Colonic irrigation system.
  16. § 876.5250 Urine collector and accessories.
  17. § 876.5270 Implanted electrical urinary continence device.
  18. § 876.5280 Implanted mechanical/hydraulic urinary continence device.
  19. § 876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories.
  20. § 876.5310 Nonimplanted, peripheral electrical continence device.
  21. § 876.5320 Nonimplanted electrical continence device.
  22. § 876.5330 Transcutaneous electrical continence device.
  23. § 876.5340 Nonimplanted nerve stimulator for functional abdominal pain relief.
  24. § 876.5365 Esophageal dilator.
  25. § 876.5450 Rectal dilator.
  26. § 876.5470 Ureteral dilator.
  27. § 876.5520 Urethral dilator.
  28. § 876.5530 Implantable transprostatic tissue retractor system.
  29. § 876.5540 Blood access device and accessories.
  30. § 876.5550 Prostatic artery embolization device.
  31. § 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
  32. § 876.5630 Peritoneal dialysis system and accessories.
  33. § 876.5665 Water purification system for hemodialysis.
  34. § 876.5820 Hemodialysis system and accessories.
  35. § 876.5830 Hemodialyzer with disposable insert (Kiil type).
  36. § 876.5860 High permeability hemodialysis system.
  37. § 876.5870 Sorbent hemoperfusion system.
  38. § 876.5880 Isolated kidney perfusion and transport system and accessories.
  39. § 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.
  40. § 876.5895 Ostomy irrigator.
  41. § 876.5900 Ostomy pouch and accessories.
  42. § 876.5920 Protective garment for incontinence.
  43. § 876.5930 Rectal control system.
  44. § 876.5955 Peritoneo-venous shunt.
  45. § 876.5960 Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.
  46. § 876.5970 Hernia support.
  47. § 876.5980 Gastrointestinal tube and accessories.
  48. § 876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.
  49. § 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.
  50. § 876.5985 Enzyme packed cartridge.
  51. § 876.5990 Extracorporeal shock wave lithotripter.