Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES


Subpart A — General Provisions
§ 876.1 Scope.
§ 876.3 Effective dates of requirement for premarket approval.
§ 876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B — Diagnostic Devices
§ 876.1075 Gastroenterology-urology biopsy instrument.
§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
§ 876.1330 Colon capsule endoscopy system.
§ 876.1400 Stomach pH electrode.
§ 876.1500 Endoscope and accessories.
§ 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
§ 876.2040 Enuresis alarm.
§ 876.2050 Prostate lesion documentation system.
Subpart D — Prosthetic Devices
§ 876.3350 Penile inflatable implant.
§ 876.3630 Penile rigidity implant.
§ 876.3750 Testicular prosthesis.
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.
§ 876.4340 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.
§ 876.4650 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.
§ 876.5015 Pancreatic drainage stent and delivery system.
§ 876.5020 External penile rigidity devices.
§ 876.5025 Vibrator for climax control of premature ejaculation.
§ 876.5030 Continent ileostomy catheter.
§ 876.5090 Suprapubic urological catheter and accessories.
§ 876.5130 Urological catheter and accessories.
§ 876.5140 Urethral insert with pump for bladder drainage.
§ 876.5160 Urological clamp for males.
§ 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.
§ 876.5310 Nonimplanted, peripheral electrical continence device.
§ 876.5320 Nonimplanted electrical continence device.
§ 876.5365 Esophageal dilator.
§ 876.5450 Rectal dilator.
§ 876.5470 Ureteral dilator.
§ 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.
§ 876.5870 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.
§ 876.5970 Hernia support.
§ 876.5980 Gastrointestinal tube and accessories.
§ 876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.
§ 876.5985 Enzyme packed cartridge.
§ 876.5990 Extracorporeal shock wave lithotripter.

Authority

21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

Source

48 FR 53023, Nov. 23, 1983, unless otherwise noted.