FDA Product Code
FDA Product Code MVR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4300
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190499 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-09-06 | Traditional | PDF ↗ |
| K191252 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-07-09 | Traditional | PDF ↗ |
| K143589 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2015-01-16 | Special | PDF ↗ |
| K142309 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2014-09-16 | Special | PDF ↗ |
| K132727 | GEM FLOW COUPLER DEVICE AND SYSTEM | Synovis Life Technologies, Inc. | 2013-10-22 | Special | PDF ↗ |
| K093310 | GEM FLOW COUPLER DEVICE AND SYSTEM | Synovis Micro Companies Alliance, Inc. | 2010-02-01 | Traditional | PDF ↗ |
| K090679 | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM | Vioptix, Inc. | 2009-04-17 | Traditional | PDF ↗ |
| K040163 | MICROVASCULAR ANASTOMOTIC DEVICE | Synovis Micro Companies Alliance, Inc. | 2004-04-16 | Traditional | PDF ↗ |
| K861985 | 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) | 3M Company | 1986-12-04 | Traditional | PDF ↗ |
Product code MVR · Class II · General, Plastic Surgery. Data: openFDA.