K143589 is an FDA 510(k) clearance for the GEM Flow COUPLER Device and System. This device is classified as a Device, Anastomotic, Microvascular (Class II - Special Controls, product code MVR).
Submitted by Synovis Life Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 16, 2015, 29 days after receiving the submission on December 18, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K143589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2014 |
| Decision Date | January 16, 2015 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MVR — Device, Anastomotic, Microvascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |