510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
ONJClass II

Dissolvable Gel For Preventing Ureteral Stone Migration

21 CFR 876.4680 / Gastroenterology, Urology
FDA source (opens on fda.gov)

ONJ is the FDA product code for Dissolvable Gel For Preventing Ureteral Stone Migration, a class II device type, regulated under 21 CFR 876.4680. FDA's definition for this code reads: "For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ONJ
Device name
Dissolvable Gel For Preventing Ureteral Stone Migration
FDA definition
For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code ONJ

By decision year
1 clearance under product code ONJ with a decision year between 2009 and 2009, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ONJ by decision year
YearClearances
20091

Applicants with the most clearances

Product code ONJ
Applicants holding the most 510(k) clearances under product code ONJ
ApplicantClearances
Pluromed, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code