510(k) K031292
K031292 is an FDA 510(k) premarket notification submitted by Fossa Medical, Inc. for the device "MODIFICATION TO FOSSA URETERAL STONE SWEEPER". The FDA issued a decision of Substantially Equivalent on May 22, 2003. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Fossa Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2003
- Date Received
- April 23, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.4620
- Review Panel
- GU
- Submission Type