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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 876GASTROENTEROLOGY-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.

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.
   § 876.4370 - 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.
   § 876.5015 - Pancreatic drainage stent and delivery system.
   § 876.5020 - External penile rigidity devices.
   § 876.5030 - Continent ileostomy catheter.
   § 876.5090 - Suprapubic urological catheter and accessories.
   § 876.5130 - Urological catheter and accessories.
   § 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 - xxx
   § 876.5540 - Blood access device and accessories.
   § 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.
   § 876.5955 - Peritoneo-venous shunt.
   § 876.5970 - Hernia support.
   § 876.5980 - Gastrointestinal tube and accessories.
   § 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.

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