Title 21, Part 876 — Gastroenterology-urology Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Endoscopic transhepatic venous access needle.

Gastroenterology-urology biopsy instrument.

Gastroenterology-urology accessories to a biopsy instrument.

Ingestible telemetric gastrointestinal capsule imaging system.

Magnetically maneuvered capsule endoscopy system.

Colon capsule endoscopy system.

Stomach pH electrode.

Esophageal tissue characterization system.

Endoscope and accessories.

Anchored esophageal sheath.

Gastrointestinal lesion software detection system.

Urodynamics measurement system.

Gastrointestinal motility monitoring system.

Electrogastrography system.

Urine flow or volume measuring system.

Enuresis alarm.

Prostate lesion documentation system.

Pressure ulcer management tool.

Penile inflatable implant.

Penile implant surgical accessories.

Penile rigidity implant.

Testicular prosthesis.

Fiberoptic light ureteral catheter.

Colostomy rod.

Endoscopic electrosurgical unit and accessories.

Endoscopic electrosurgical clip cutting system.

Endoscopic pancreatic debridement device.

High intensity ultrasound system for prostate tissue ablation.

Fluid jet system for prostate tissue removal.

Gastroenterology-urology evacuator.

Hemorrhoidal ligator.

Electrohydraulic lithotriptor.

Mechanical lithotriptor.

Gastroenterology-urology fiberoptic retractor.

Ribdam.

Interlocking urethral sound.

Ureteral stent.

Ureteral stent accessories.

Water jet renal stone dislodger system.

Ureteral stone dislodger.

Manual gastroenterology-urology surgical instrument and accessories.

Urethrotome.

Urological table and accessories.

Biliary catheter and accessories.

Metallic biliary stent system for benign strictures.

Biliary stent, drain, and dilator accessories.

Pancreatic drainage stent and delivery system.

External penile rigidity devices.

Vibrator for climax control of premature ejaculation.

Non-implanted electrical stimulation device for management of premature ejaculation.

Continent ileostomy catheter.

Suprapubic urological catheter and accessories.

Suprapubic catheter accessories.

Urological catheter and accessories.

Urethral insert with pump for bladder drainage.

Urological clamp.

Enema kit.

Colonic irrigation system.

Urine collector and accessories.

Implanted electrical urinary continence device.

Implanted mechanical/hydraulic urinary continence device.

Implanted mechanical/hydraulic urinary continence device surgical accessories.

Nonimplanted, peripheral electrical continence device.

Nonimplanted electrical continence device.

Transcutaneous electrical continence device.

Nonimplanted nerve stimulator for functional abdominal pain relief.

Laparoscopic gastrointestinal sizing tool.

Esophageal dilator.

Rectal dilator.

Ureteral dilator.

Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia.

Urethral dilator.

Implantable transprostatic tissue retractor system.

Blood access device and accessories.

Prostatic artery embolization device.

Sorbent regenerated dialysate delivery system for hemodialysis.

Peritoneal dialysis system and accessories.

Water purification system for hemodialysis.

Hemodialysis system and accessories.

Hemodialyzer with disposable insert (Kiil type).

High permeability hemodialysis system.

Pediatric continuous renal replacement therapy system.

Hemodialyzer with expanded solute removal profile.

Sorbent hemoperfusion system.

Isolated kidney perfusion and transport system and accessories.

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

Ostomy irrigator.

Ostomy pouch and accessories.

Protective garment for incontinence.

Rectal control system.

Peritoneo-venous shunt.

Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.

Hernia support.

Gastrointestinal tube and accessories.

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

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

Enzyme packed cartridge.

Extracorporeal shock wave lithotripter.