K040163 is an FDA 510(k) clearance for the MICROVASCULAR ANASTOMOTIC DEVICE. This device is classified as a Device, Anastomotic, Microvascular (Class II - Special Controls, product code MVR).
Submitted by Synovis Micro Companies Alliance, Inc. (Birmingham, US). The FDA issued a Cleared decision on April 16, 2004, 81 days after receiving the submission on January 26, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K040163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2004 |
| Decision Date | April 16, 2004 |
| Days to Decision | 81 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 |