CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 876—GASTROENTEROLOGY-UROLOGY DEVICES > SUBPART F—Therapeutic Devices (§876.5010 to §876.5990) > 876.5030—Continent ileostomy catheter.

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 § 876.9.

Code of Federal Regulations

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