eCFR Browser Home Search Bookmarks Admin

eCFR Structure

Browse the hierarchical structure

Loading Part...

Official eCFR Website

eCFR Browser Home Search Bookmarks Admin

eCFR Structure

Browse the hierarchical structure

Loading Part...

Official eCFR Website

Initializing...

Title 21 - Title 21

Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES

0 bookmarked

Browse sections within this part

Part Information

Details about Part 876

Description

MEDICAL DEVICES - GASTROENTEROLOGY-UROLOGY DEVICES

Official eCFR Link

View on eCFR.gov

Sections in this Part

Browse sections within Part 876

79 sections

§876.1 - Scope.

Title 21, Part 876

§876.1075 - Gastroenterology-urology biopsy instrument.

Title 21, Part 876

§876.1300 - Ingestible telemetric gastrointestinal capsule imaging system.

Title 21, Part 876

§876.1330 - Colon capsule endoscopy system.

Title 21, Part 876

§876.1400 - Stomach pH electrode.

Title 21, Part 876

§876.1500 - Endoscope and accessories.

Title 21, Part 876

§876.1620 - Urodynamics measurement system.

Title 21, Part 876

§876.1725 - Gastrointestinal motility monitoring system.

Title 21, Part 876

§876.1735 - Electrogastrography system.

Title 21, Part 876

§876.1800 - Urine flow or volume measuring system.

Title 21, Part 876

§876.2040 - Enuresis alarm.

Title 21, Part 876

§876.2050 - Prostate lesion documentation system.

Title 21, Part 876

§876.3 - Effective dates of requirement for premarket approval.

Title 21, Part 876

§876.3350 - Penile inflatable implant.

Title 21, Part 876

§876.3630 - Penile rigidity implant.

Title 21, Part 876

§876.3750 - Testicular prosthesis.

Title 21, Part 876

§876.4020 - Fiberoptic light ureteral catheter.

Title 21, Part 876

§876.4270 - Colostomy rod.

Title 21, Part 876

§876.4300 - Endoscopic electrosurgical unit and accessories.

Title 21, Part 876

§876.4310 - Endoscopic electrosurgical clip cutting system.

Title 21, Part 876

§876.4340 - High intensity ultrasound system for prostate tissue ablation.

Title 21, Part 876

§876.4350 - Fluid jet system for prostate tissue removal.

Title 21, Part 876

§876.4370 - Gastroenterology-urology evacuator.

Title 21, Part 876

§876.4400 - Hemorrhoidal ligator.

Title 21, Part 876

§876.4480 - Electrohydraulic lithotriptor.

Title 21, Part 876

§876.4500 - Mechanical lithotriptor.

Title 21, Part 876

§876.4530 - Gastroenterology-urology fiberoptic retractor.

Title 21, Part 876

§876.4560 - Ribdam.

Title 21, Part 876

§876.4590 - Interlocking urethral sound.

Title 21, Part 876

§876.4620 - Ureteral stent.

Title 21, Part 876

§876.4650 - Water jet renal stone dislodger system.

Title 21, Part 876

§876.4680 - Ureteral stone dislodger.

Title 21, Part 876

§876.4730 - Manual gastroenterology-urology surgical instrument and accessories.

Title 21, Part 876

§876.4770 - Urethrotome.

Title 21, Part 876

§876.4890 - Urological table and accessories.

Title 21, Part 876

§876.5010 - Biliary catheter and accessories.

Title 21, Part 876

§876.5011 - Metallic biliary stent system for benign strictures.

Title 21, Part 876

§876.5015 - Pancreatic drainage stent and delivery system.

Title 21, Part 876

§876.5020 - External penile rigidity devices.

Title 21, Part 876

§876.5025 - Vibrator for climax control of premature ejaculation.

Title 21, Part 876

§876.5030 - Continent ileostomy catheter.

Title 21, Part 876

§876.5090 - Suprapubic urological catheter and accessories.

Title 21, Part 876

§876.5130 - Urological catheter and accessories.

Title 21, Part 876

§876.5140 - Urethral insert with pump for bladder drainage.

Title 21, Part 876

§876.5160 - Urological clamp for males.

Title 21, Part 876

§876.5210 - Enema kit.

Title 21, Part 876

§876.5220 - Colonic irrigation system.

Title 21, Part 876

§876.5250 - Urine collector and accessories.

Title 21, Part 876

§876.5270 - Implanted electrical urinary continence device.

Title 21, Part 876

§876.5280 - Implanted mechanical/hydraulic urinary continence device.

Title 21, Part 876

§876.5310 - Nonimplanted, peripheral electrical continence device.

Title 21, Part 876

§876.5320 - Nonimplanted electrical continence device.

Title 21, Part 876

§876.5365 - Esophageal dilator.

Title 21, Part 876

§876.5450 - Rectal dilator.

Title 21, Part 876

§876.5470 - Ureteral dilator.

Title 21, Part 876

§876.5520 - Urethral dilator.

Title 21, Part 876

§876.5530 - Implantable transprostatic tissue retractor system.

Title 21, Part 876

§876.5540 - Blood access device and accessories.

Title 21, Part 876

§876.5550 - Prostatic artery embolization device.

Title 21, Part 876

§876.5600 - Sorbent regenerated dialysate delivery system for hemodialysis.

Title 21, Part 876

§876.5630 - Peritoneal dialysis system and accessories.

Title 21, Part 876

§876.5665 - Water purification system for hemodialysis.

Title 21, Part 876

§876.5820 - Hemodialysis system and accessories.

Title 21, Part 876

§876.5830 - Hemodialyzer with disposable insert (Kiil type).

Title 21, Part 876

§876.5860 - High permeability hemodialysis system.

Title 21, Part 876

§876.5870 - Sorbent hemoperfusion system.

Title 21, Part 876

§876.5880 - Isolated kidney perfusion and transport system and accessories.

Title 21, Part 876

§876.5885 - Tissue culture media for human ex vivo tissue and cell culture processing applications.

Title 21, Part 876

§876.5895 - Ostomy irrigator.

Title 21, Part 876

§876.5900 - Ostomy pouch and accessories.

Title 21, Part 876

§876.5920 - Protective garment for incontinence.

Title 21, Part 876

§876.5930 - Rectal control system.

Title 21, Part 876

§876.5955 - Peritoneo-venous shunt.

Title 21, Part 876

§876.5970 - Hernia support.

Title 21, Part 876

§876.5980 - Gastrointestinal tube and accessories.

Title 21, Part 876

§876.5981 - Oral removable palatal space occupying device for weight management and/or weight loss.

Title 21, Part 876

§876.5985 - Enzyme packed cartridge.

Title 21, Part 876

§876.5990 - Extracorporeal shock wave lithotripter.

Title 21, Part 876

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

Title 21, Part 876