eCFR Reference Browser

---

title: "21 CFR §876.4020"

source: "https://www.ecfr.gov/current/title-21/section-876.4020"

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: "E"

subpart_subject: "Surgical Devices"

section_number: "876.4020"

section_subject: "Fiberoptic light ureteral catheter."

cfr_reference: "21 CFR 876.4020"

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 fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits light throughout its length and is shaped so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.

(b)Classification. Class II (performance standards).

§876.4020 - Fiberoptic light ureteral catheter.