21 CFR Part 876
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
- PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical 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
- § 876.1050 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.
- § 876.1390 Ingestible gastrointestinal blood detection capsule.
- § 876.1400 Stomach pH electrode.
- § 876.1450 Esophageal tissue characterization system.
- § 876.1500 Endoscope and accessories.
- § 876.1510 Anchored esophageal sheath.
- § 876.1520 Gastrointestinal lesion software detection system.
- § 876.1530 Endoscopic light-projecting measuring device.
- § 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.
- § 876.2100 Pressure ulcer management tool.
- Subpart D—Prosthetic Devices
- § 876.3350 Penile inflatable implant.
- § 876.3500 Penile implant surgical accessories.
- § 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.
- § 876.4330 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.
- § 876.4410 Endoscopic traction device.
- § 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.
- § 876.5021 Non-medicated topical formulation for treatment of erectile dysfunction.
- § 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.
- § 876.5940 Orally ingested transient device for constipation.
- § 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.
- § 876.5983 Endoscopic suturing device for altering gastric anatomy for weight loss.
- § 876.5985 Enzyme packed cartridge.
- § 876.5990 Extracorporeal shock wave lithotripter.
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