21 CFR 876.5030 — Catheter, Rectal For Continent Ileostomy

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5030

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.

Classification Rationale

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.

Product Codes