Part 876 — Gastroenterology-Urology Devices
Subpart A — General Provisions
Subpart B — Diagnostic Devices
- § 876.1050— Endoscopic transhepatic venous access needle.
- § 876.1075— Gastroenterology-urology biopsy instrument.
- § 876.1080— Gastroenterology-urology accessories to a biopsy instrument.
- § 876.1300— Ingestible telemetric gastrointestinal capsule imaging system.
- § 876.1310— Magnetically maneuvered capsule endoscopy system.
- § 876.1330— Colon capsule endoscopy system.
- § 876.1400— Stomach pH electrode.
- § 876.1450— Esophageal tissue characterization system.
- § 876.1500— Endoscope and accessories.
- § 876.1520— Gastrointestinal lesion software detection system.
- § 876.1620— Urodynamics measurement system.
- § 876.1725— Gastrointestinal motility monitoring system.
- § 876.1735— Electrogastrography system.
- § 876.1800— Urine flow or volume measuring system.
Subpart C — Monitoring Devices
Subpart D — Prosthetic Devices
Subpart E — Surgical Devices
- § 876.4020— Fiberoptic light ureteral catheter.
- § 876.4270— Colostomy rod.
- § 876.4300— Endoscopic electrosurgical unit and accessories.
- § 876.4310— Endoscopic electrosurgical clip cutting system.
- § 876.4330— Endoscopic pancreatic debridement device.
- § 876.4340— High intensity ultrasound system for prostate tissue ablation.
- § 876.4350— Fluid jet system for prostate tissue removal.
- § 876.4370— Gastroenterology-urology evacuator.
- § 876.4400— Hemorrhoidal ligator.
- § 876.4480— Electrohydraulic lithotriptor.
- § 876.4500— Mechanical lithotriptor.
- § 876.4530— Gastroenterology-urology fiberoptic retractor.
- § 876.4560— Ribdam.
- § 876.4590— Interlocking urethral sound.
- § 876.4620— Ureteral stent.
- § 876.4630— Ureteral stent accessories.
- § 876.4650— Water jet renal stone dislodger system.
- § 876.4680— Ureteral stone dislodger.
- § 876.4730— Manual gastroenterology-urology surgical instrument and accessories.
- § 876.4770— Urethrotome.
- § 876.4890— Urological table and accessories.
Subpart F — Therapeutic Devices
- § 876.5010— Biliary catheter and accessories.
- § 876.5011— Metallic biliary stent system for benign strictures.
- § 876.5012— Biliary stent, drain, and dilator accessories.
- § 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— Suprapubic catheter accessories.
- § 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— Implanted mechanical/hydraulic urinary continence device surgical accessories.
- § 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.
- § 876.5360— Laparoscopic gastrointestinal sizing tool.
- § 876.5365— Esophageal dilator.
- § 876.5450— Rectal dilator.
- § 876.5470— Ureteral dilator.
- § 876.5510— Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia.
- § 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.
- § 876.5861— Pediatric continuous renal replacement therapy system.
- § 876.5862— Hemodialyzer with expanded solute removal profile.
- § 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.