510(k) K902265
K902265 is an FDA 510(k) premarket notification submitted by Annex Medical, Inc. for the device "FLEXIBLE SNARE". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Annex Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1990
- Date Received
- May 21, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Snare, Flexible
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type