K132727 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 October 22, 2013, 49 days after receiving the submission on September 3, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K132727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2013 |
| Decision Date | October 22, 2013 |
| Days to Decision | 49 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 |