21 C.F.R. PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
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.
|
|
