Device, Anastomotic, Microvascular
FDA product code MVR · Class II (moderate risk) · 21 CFR 878.4300 · General, Plastic Surgery
9510(k) clearances
0PMA approvals
6recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190499 | Gem FlowCoupler SystemMVR · Traditional | Baxter/ Synovis Micro Companies Alliance, Inc. | 09/06/2019SE |
| K191252 | Gem FlowCoupler SystemMVR · Traditional | Baxter/ Synovis Micro Companies Alliance, Inc. | 07/09/2019SE |
| K143589 | GEM Flow COUPLER Device and SystemMVR · Special | Synovis Life Technologies, Inc. | 01/16/2015SE |
| K142309 | GEM Flow COUPLER Device and SystemMVR · Special | Synovis Life Technologies, Inc. | 09/16/2014SE |
| K132727 | Gem Flow Coupler Device and SystemMVR · Special | Synovis Life Technologies, Inc. | 10/22/2013SE |
| K093310 | Gem Flow Coupler Device and SystemMVR · Traditional | Synovis Micro Companies Alliance, Inc. | 02/01/2010SE |
| K090679 | Vesselink Microvascular Anastomotic Coupler SystemMVR · Traditional | Vioptix, Inc. | 04/17/2009SE |
| K040163 | Microvascular Anastomotic DeviceMVR · Traditional | Synovis Micro Companies Alliance, Inc. | 04/16/2004SE |
| K861985 | 3M Brand Microvascular Anastomotic Coupler (27XX)MVR · Traditional | 3M Company | 12/04/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0939-2021 Class II | FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm…Potential for the battery to lose its ability to be recharged. | Baxter Healthcare Corporation | 12/28/2020Open, Classified |
| Z-2474-2020 Class II | Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx OnlyA firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi… | Baxter Healthcare Corporation | 06/02/2020Open, Classified |
| Z-1687-2020 Class II | GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis…The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the… | Baxter Healthcare Corporation | 03/05/2020Terminated |
| Z-1686-2020 Class II | GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in…The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the… | Baxter Healthcare Corporation | 03/05/2020Terminated |
| Z-1685-2020 Class II | GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in…The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the… | Baxter Healthcare Corporation | 03/05/2020Terminated |
| Z-2138-2008 | GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010…Coupler rings may slip out of the delivery toolcaused by jaws larger than specification. | Synovis Micro Companies Alliance Inc | 05/14/2008Terminated |