Therapeutic Devices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Gastroenterology-Urology Devices
  7. Therapeutic Devices

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Section
876.5010

Biliary catheter and accessories.

Section
876.5011

Metallic biliary stent system for benign strictures.

Section
876.5012

Biliary stent, drain, and dilator accessories.

Section
876.5015

Pancreatic drainage stent and delivery system.

Section
876.5020

External penile rigidity devices.

Section
876.5025

Vibrator for climax control of premature ejaculation.

Section
876.5030

Continent ileostomy catheter.

Section
876.5090

Suprapubic urological catheter and accessories.

Section
876.5100

Suprapubic catheter accessories.

Section
876.5130

Urological catheter and accessories.

Section
876.5140

Urethral insert with pump for bladder drainage.

Section
876.5160

Urological clamp.

Section
876.5210

Enema kit.

Section
876.5220

Colonic irrigation system.

Section
876.5250

Urine collector and accessories.

Section
876.5270

Implanted electrical urinary continence device.

Section
876.5280

Implanted mechanical/hydraulic urinary continence device.

Section
876.5290

Implanted mechanical/hydraulic urinary continence device surgical accessories.

Section
876.5310

Nonimplanted, peripheral electrical continence device.

Section
876.5320

Nonimplanted electrical continence device.

Section
876.5330

Transcutaneous electrical continence device.

Section
876.5340

Nonimplanted nerve stimulator for functional abdominal pain relief.

Section
876.5365

Esophageal dilator.

Section
876.5450

Rectal dilator.

Section
876.5470

Ureteral dilator.

Section
876.5520

Urethral dilator.

Section
876.5530

Implantable transprostatic tissue retractor system.

Section
876.5540

Blood access device and accessories.

Section
876.5550

Prostatic artery embolization device.

Section
876.5600

Sorbent regenerated dialysate delivery system for hemodialysis.

Section
876.5630

Peritoneal dialysis system and accessories.

Section
876.5665

Water purification system for hemodialysis.

Section
876.5820

Hemodialysis system and accessories.

Section
876.5830

Hemodialyzer with disposable insert (Kiil type).

Section
876.5860

High permeability hemodialysis system.

Section
876.5870

Sorbent hemoperfusion system.

Section
876.5880

Isolated kidney perfusion and transport system and accessories.

Section
876.5885

Tissue culture media for human ex vivo tissue and cell culture processing applications.

Section
876.5895

Ostomy irrigator.

Section
876.5900

Ostomy pouch and accessories.

Section
876.5920

Protective garment for incontinence.

Section
876.5930

Rectal control system.

Section
876.5955

Peritoneo-venous shunt.

Section
876.5970

Hernia support.

Section
876.5980

Gastrointestinal tube and accessories.

Section
876.5981

Oral removable palatal space occupying device for weight management and/or weight loss.

Section
876.5982

Ingested, transient, space occupying device for weight management and/or weight loss.

Section
876.5985

Enzyme packed cartridge.

Section
876.5990

Extracorporeal shock wave lithotripter.