K190499 is an FDA 510(k) clearance for the Gem FlowCoupler System. This device is classified as a Device, Anastomotic, Microvascular (Class II - Special Controls, product code MVR).
Submitted by Baxter/ Synovis Micro Companies Alliance, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 6, 2019, 189 days after receiving the submission on March 1, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K190499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2019 |
| Decision Date | September 06, 2019 |
| Days to Decision | 189 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 |