Product code
ONJ: Dissolvable gel for preventing ureteral stone migration
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | ONJ |
|---|---|
| Device | Dissolvable gel for preventing ureteral stone migration |
| Device class | Class II |
| Regulation number | 876.4680 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database