ONJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dissolvable Gel For Preventing Ureteral Stone Migration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4680
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
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| Record | Firm | Date |
|---|---|---|
| BACKSTOP AND BACKSTOP INJECTOR (K090430) | Pluromed, Inc. | 2009-06-02 |
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