510(k) K090430
K090430 is an FDA 510(k) premarket notification submitted by Pluromed, Inc. for the device "BACKSTOP AND BACKSTOP INJECTOR". The FDA issued a decision of Substantially Equivalent on Jun 2, 2009. The device falls under product code ONJ (Dissolvable Gel For Preventing Ureteral Stone Migration), a Class II device regulated under 21 CFR 876.4680. Pluromed, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 2009
- Date Received
- Feb 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dissolvable Gel For Preventing Ureteral Stone Migration
- Device Class
- Class II
- Regulation Number
- 876.4680
- Review Panel
- GU
- Submission Type
For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.