21 C.F.R. § 876.5030 Continent ileostomy catheter.
Title 21 - Food and Drugs
(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. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 66 FR 38801, July 25, 2001]
Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F—Therapeutic Devices
§ 876.5030 Continent ileostomy catheter.
