ONJ

Dissolvable Gel For Preventing Ureteral Stone Migration

Product code

ONJ

Device name

Dissolvable Gel For Preventing Ureteral Stone Migration

Device class

Class 2

21 CFR

21 CFR 876.4680

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.

Definition text from the FDA device classification database (U.S. federal government work, public domain).