FDA product code ONJ: Dissolvable Gel For Preventing Ureteral Stone Migration
ONJ is the FDA product code for dissolvable gel for preventing ureteral stone migration. It is a Class II device, regulated under 21 CFR 876.4680 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under ONJ. The average 510(k) review took 103 days (median 103).
Definition
For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
Classification
| Field | Value |
|---|---|
| Device name | Dissolvable Gel For Preventing Ureteral Stone Migration |
| Device class | Class II |
| Regulation | 21 CFR 876.4680 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ONJ clearance
Top ONJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pluromed, Inc. | 1 | 2009-06-02 |
Most recent ONJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090430 | Pluromed, Inc. | BACKSTOP AND BACKSTOP INJECTOR | 2009-06-02 | 103 |
Recalls for ONJ devices
openFDA lists no recalls for product code ONJ.
Frequently asked questions
What is FDA product code ONJ?
ONJ is the FDA product code for dissolvable gel for preventing ureteral stone migration. It is a Class II device, regulated under 21 CFR 876.4680 and reviewed by the Gastroenterology and Urology panel.
What device class is ONJ?
Class II, regulation 21 CFR 876.4680. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ONJ?
Across 1 cleared submissions the average was 103 days from receipt to decision (median 103).
Which companies have the most ONJ clearances?
Pluromed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ONJ
- Run a recall and safety report across every ONJ manufacturer
- Watch product code ONJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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