Therapeutic Devices | Midpage

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Code of Federal Regulations

Subpart F

Therapeutic Devices

876.5010Biliary catheter and accessories.876.5011Metallic biliary stent system for benign strictures.876.5012Biliary stent, drain, and dilator accessories.876.5015Pancreatic drainage stent and delivery system.876.5020External penile rigidity devices.876.5025Vibrator for climax control of premature ejaculation.876.5026Non-implanted electrical stimulation device for management of premature ejaculation.876.5030Continent ileostomy catheter.876.5090Suprapubic urological catheter and accessories.876.5100Suprapubic catheter accessories.876.5130Urological catheter and accessories.876.5140Urethral insert with pump for bladder drainage.876.5160Urological clamp.876.5210Enema kit.876.5220Colonic irrigation system.876.5250Urine collector and accessories.876.5270Implanted electrical urinary continence device.876.5280Implanted mechanical/hydraulic urinary continence device.876.5290Implanted mechanical/hydraulic urinary continence device surgical accessories.876.5310Nonimplanted, peripheral electrical continence device.876.5320Nonimplanted electrical continence device.876.5330Transcutaneous electrical continence device.876.5340Nonimplanted nerve stimulator for functional abdominal pain relief.876.5360Laparoscopic gastrointestinal sizing tool.876.5365Esophageal dilator.876.5450Rectal dilator.876.5470Ureteral dilator.876.5510Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia.876.5520Urethral dilator.876.5530Implantable transprostatic tissue retractor system.876.5540Blood access device and accessories.876.5550Prostatic artery embolization device.876.5600Sorbent regenerated dialysate delivery system for hemodialysis.876.5630Peritoneal dialysis system and accessories.876.5665Water purification system for hemodialysis.876.5820Hemodialysis system and accessories.876.5830Hemodialyzer with disposable insert (Kiil type).876.5860High permeability hemodialysis system.876.5861Pediatric continuous renal replacement therapy system.876.5862Hemodialyzer with expanded solute removal profile.876.5870Sorbent hemoperfusion system.876.5880Isolated kidney perfusion and transport system and accessories.876.5885Tissue culture media for human ex vivo tissue and cell culture processing applications.876.5895Ostomy irrigator.876.5900Ostomy pouch and accessories.876.5920Protective garment for incontinence.876.5930Rectal control system.876.5940Orally ingested transient device for constipation.876.5955Peritoneo-venous shunt.876.5960Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.876.5970Hernia support.876.5980Gastrointestinal tube and accessories.876.5981Oral removable palatal space occupying device for weight management and/or weight loss.876.5982Ingested, transient, space occupying device for weight management and/or weight loss.876.5983Endoscopic suturing device for altering gastric anatomy for weight loss.876.5985Enzyme packed cartridge.876.5990Extracorporeal shock wave lithotripter.