Subpart F - Therapeutic Devices


§ 876.5010 - Biliary catheter and accessories.
§ 876.5011 - Metallic biliary stent system for benign strictures.
§ 876.5012 - xxx
§ 876.5015 - Pancreatic drainage stent and delivery system.
§ 876.5020 - External penile rigidity devices.
§ 876.5025 - Vibrator for climax control of premature ejaculation.
§ 876.5026 - Non-implanted electrical stimulation device for management of premature ejaculation.
§ 876.5030 - Continent ileostomy catheter.
§ 876.5090 - Suprapubic urological catheter and accessories.
§ 876.5100 - xxx
§ 876.5130 - Urological catheter and accessories.
§ 876.5140 - Urethral insert with pump for bladder drainage.
§ 876.5160 - Urological clamp.
§ 876.5210 - Enema kit.
§ 876.5220 - Colonic irrigation system.
§ 876.5250 - Urine collector and accessories.
§ 876.5270 - Implanted electrical urinary continence device.
§ 876.5280 - Implanted mechanical/hydraulic urinary continence device.
§ 876.5290 - xxx
§ 876.5310 - Nonimplanted, peripheral electrical continence device.
§ 876.5320 - Nonimplanted electrical continence device.
§ 876.5330 - Transcutaneous electrical continence device.
§ 876.5340 - Nonimplanted nerve stimulator for functional abdominal pain relief.
§ 876.5365 - Esophageal dilator.
§ 876.5450 - Rectal dilator.
§ 876.5470 - Ureteral dilator.
§ 876.5520 - Urethral dilator.
§ 876.5530 - Implantable transprostatic tissue retractor system.
§ 876.5540 - Blood access device and accessories.
§ 876.5550 - Prostatic artery embolization device.
§ 876.5600 - Sorbent regenerated dialysate delivery system for hemodialysis.
§ 876.5630 - Peritoneal dialysis system and accessories.
§ 876.5665 - Water purification system for hemodialysis.
§ 876.5820 - Hemodialysis system and accessories.
§ 876.5830 - Hemodialyzer with disposable insert (Kiil type).
§ 876.5860 - High permeability hemodialysis system.
§ 876.5870 - Sorbent hemoperfusion system.
§ 876.5880 - Isolated kidney perfusion and transport system and accessories.
§ 876.5885 - Tissue culture media for human ex vivo tissue and cell culture processing applications.
§ 876.5895 - Ostomy irrigator.
§ 876.5900 - Ostomy pouch and accessories.
§ 876.5920 - Protective garment for incontinence.
§ 876.5930 - Rectal control system.
§ 876.5955 - Peritoneo-venous shunt.
§ 876.5960 - Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.
§ 876.5970 - Hernia support.
§ 876.5980 - Gastrointestinal tube and accessories.
§ 876.5981 - Oral removable palatal space occupying device for weight management and/or weight loss.
§ 876.5982 - Ingested, transient, space occupying device for weight management and/or weight loss.
§ 876.5985 - Enzyme packed cartridge.
§ 876.5990 - Extracorporeal shock wave lithotripter.