Product code ONJ
- Device name
- Dissolvable Gel For Preventing Ureteral Stone Migration
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4680
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
- Source
- FDA openFDA device classification dataset