ONJ — Dissolvable Gel For Preventing Ureteral Stone Migration Class II
FDA product code ONJ covers "Dissolvable Gel For Preventing Ureteral Stone Migration", a Class II medical device regulated under 21 CFR 876.4680. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K090430 | Pluromed | BACKSTOP AND BACKSTOP INJECTOR | Jun 2, 2009 |