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FEDERAL · 21 CFR

Part 876 — Gastroenterology-Urology Devices

101 sections · Title 21: Food and Drugs

§ 876.1Scope.
§ 876.3Effective dates of requirement for premarket approval.
§ 876.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 876.1050Endoscopic transhepatic venous access needle.
§ 876.1075Gastroenterology-urology biopsy instrument.
§ 876.1080Gastroenterology-urology accessories to a biopsy instrument.
§ 876.1300Ingestible telemetric gastrointestinal capsule imaging system.
§ 876.1310Magnetically maneuvered capsule endoscopy system.
§ 876.1330Colon capsule endoscopy system.
§ 876.1400Stomach pH electrode.
§ 876.1450Esophageal tissue characterization system.
§ 876.1500Endoscope and accessories.
§ 876.1510Anchored esophageal sheath.
§ 876.1520Gastrointestinal lesion software detection system.
§ 876.1620Urodynamics measurement system.
§ 876.1725Gastrointestinal motility monitoring system.
§ 876.1735Electrogastrography system.
§ 876.1800Urine flow or volume measuring system.
§ 876.2040Enuresis alarm.
§ 876.2050Prostate lesion documentation system.
§ 876.2100Pressure ulcer management tool.
§ 876.3350Penile inflatable implant.
§ 876.3500Penile implant surgical accessories.
§ 876.3630Penile rigidity implant.
§ 876.3750Testicular prosthesis.
§ 876.4020Fiberoptic light ureteral catheter.
§ 876.4270Colostomy rod.
§ 876.4300Endoscopic electrosurgical unit and accessories.
§ 876.4310Endoscopic electrosurgical clip cutting system.
§ 876.4330Endoscopic pancreatic debridement device.
§ 876.4340High intensity ultrasound system for prostate tissue ablation.
§ 876.4350Fluid jet system for prostate tissue removal.
§ 876.4370Gastroenterology-urology evacuator.
§ 876.4400Hemorrhoidal ligator.
§ 876.4480Electrohydraulic lithotriptor.
§ 876.4500Mechanical lithotriptor.
§ 876.4530Gastroenterology-urology fiberoptic retractor.
§ 876.4560Ribdam.
§ 876.4590Interlocking urethral sound.
§ 876.4620Ureteral stent.
§ 876.4630Ureteral stent accessories.
§ 876.4650Water jet renal stone dislodger system.
§ 876.4680Ureteral stone dislodger.
§ 876.4730Manual gastroenterology-urology surgical instrument and accessories.
§ 876.4770Urethrotome.
§ 876.4890Urological table and accessories.
§ 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.
§ 876.5955Peritoneo-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.
§ 876.5985Enzyme packed cartridge.
§ 876.5990Extracorporeal shock wave lithotripter.