21 CFR § 876.5470 Gastroenterology-Urology Devices

§ 876.5470 Ureteral dilator.

Current through Sep 8, 2026 · Read all of Part 876

(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).

← § 876.5450 Rectal dilator.§ 876.5510 Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia. →