eCFR Reference Browser

---

title: "21 CFR §876.5030"

source: "https://www.ecfr.gov/current/title-21/section-876.5030"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "876"

part_subject: "GASTROENTEROLOGY-UROLOGY DEVICES"

subpart_code: "F"

subpart_subject: "Therapeutic Devices"

section_number: "876.5030"

section_subject: "Continent ileostomy catheter."

cfr_reference: "21 CFR 876.5030"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§876.5030 - Continent ileostomy catheter.