510(k) K143589
K143589 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies, Inc. for the device "GEM Flow COUPLER Device and System". The FDA issued a decision of Substantially Equivalent on January 16, 2015. The device falls under product code MVR (Device, Anastomotic, Microvascular), a Class II device regulated under 21 CFR 878.4300. Synovis Life Technologies, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2015
- Date Received
- December 18, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anastomotic, Microvascular
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type