|
Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
Subpart A--GENERAL PROVISIONS
|
| Effective dates of requirement for premarket approval. |
|
|
| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
|
Subpart B--DIAGNOSTIC DEVICES
|
| Gastroenterology-urology biopsy instrument. |
|
|
| Ingestible telemetric gastrointestinal capsule imaging system. |
|
|
| Endoscope and accessories. |
|
|
| Urodynamics measurement system. |
|
|
| Gastrointestinal motility monitoring system. |
|
|
| Electrogastrography system. |
|
|
| Urine flow or volume measuring system. |
|
Subpart C--MONITORING DEVICES
Subpart D--PROSTHETIC DEVICES
|
| Penile inflatable implant. |
|
Subpart E--SURGICAL DEVICES
|
| Fiberoptic light ureteral catheter. |
|
|
| Endoscopic electrosurgical unit and accessories. |
|
|
| Gastroenterology-urology evacuator. |
|
|
| Electrohydraulic lithotriptor. |
|
|
| Gastroenterology-urology fiberoptic retractor. |
|
|
| Interlocking urethral sound. |
|
|
| Water jet renal stone dislodger system. |
|
|
| Ureteral stone dislodger. |
|
|
| Manual gastroenterology-urology surgical instrument and accessories. |
|
|
| Urological table and accessories. |
|
Subpart F--THERAPEUTIC DEVICES
|
| Biliary catheter and accessories. |
|
|
| External penile rigidity devices. |
|
|
| Continent ileostomy catheter. |
|
|
| Suprapubic urological catheter and accessories. |
|
|
| Urological catheter and accessories. |
|
|
| Urological clamp for males. |
|
|
| Colonic irrigation system. |
|
|
| Urine collector and accessories. |
|
|
| Implanted electrical urinary continence device. |
|
|
| Implanted mechanical/hydraulic urinary continence device. |
|
|
| Nonimplanted, peripheral electrical continence device. |
|
|
| Nonimplanted electrical continence device. |
|
|
| Blood access device and accessories. |
|
|
| Sorbent regenerated dialysate delivery system for hemodialysis. |
|
|
| Peritoneal dialysis system and accessories. |
|
|
| Water purification system for hemodialysis. |
|
|
| Hemodialysis system and accessories. |
|
|
| Hemodialyzer with disposable insert (Kiil type). |
|
|
| High permeability hemodialysis system. |
|
|
| Sorbent hemoperfusion system. |
|
|
| Isolated kidney perfusion and transport system and accessories. |
|
|
| Tissue culture media for human ex vivo tissue and cell culture processing applications. |
|
|
| Ostomy pouch and accessories. |
|
|
| Protective garment for incontinence. |
|
|
| Gastrointestinal tube and accessories. |
|
|
| Extracorporeal shock wave lithotripter. |
|
|
