21 CFR § 876.5470 - Ureteral dilator.

---
identifier: "/us/cfr/t21/s876.5470"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.5470 - Ureteral dilator."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.5470"
section_name: "Ureteral dilator."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 876.5470 Ureteral dilator.

(a) *Identification.* A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

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