[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5030]

[Page 366]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                     Subpart F--Therapeutic Devices
 
Sec. 876.5030  Continent ileostomy catheter.

    (a) Identification. A continent ileostomy catheter is a flexible 
tubular device used as a form during surgery for continent ileostomy and 
it provides drainage after surgery. Additionally, the device may be 
inserted periodically by the patient for routine care to empty the ileal 
pouch. This generic type of device includes the rectal catheter for 
continent ileostomy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 
66 FR 38801, July 25, 2001]