ONJ — Dissolvable Gel For Preventing Ureteral Stone Migration Class II

FDA Device Classification

Classification Details

Product Code
ONJ
Device Class
Class II
Regulation Number
876.4680
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K090430pluromedBACKSTOP AND BACKSTOP INJECTORJune 2, 2009