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Title 21

Displaying title 21, up to date as of 7/15/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 876Gastroenterology-Urology Devices876.1 – 876.5990
Subpart FTherapeutic Devices876.5010 – 876.5990
§ 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.