K093310 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 Micro Companies Alliance, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 1, 2010, 102 days after receiving the submission on October 22, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K093310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2009 |
| Decision Date | February 01, 2010 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| 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 |