510(k) K992391
K992391 is an FDA 510(k) premarket notification submitted by Urosurge, Inc. for the device "UROSURGE SPIRALFLO URETERAL STENT". The FDA issued a decision of Substantially Equivalent on Aug 18, 1999. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Urosurge, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 1999
- Date Received
- Jul 19, 1999
- Clearance Type
- Traditional
- 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
- 510(k)