DeviceClearance

Product code ONJ— Gastroenterology, Urology

BACKSTOP AND BACKSTOP INJECTOR

Classification name
Dissolvable Gel For Preventing Ureteral Stone Migration
Device class
Class 2
Regulation
21 CFR 876.4680
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code ONJ under 21 CFR 876.4680, via openFDA

Market context for product code ONJ

FDA has cleared 1 device under product code ONJ, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code ONJ

Recent clearances under product code ONJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.