MVR · Device, Anastomotic, Microvascular
General, Plastic Surgery · 21 CFR 878.4300 · Class 2
Overview
| Product Code | MVR |
|---|---|
| Device Name | Device, Anastomotic, Microvascular |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Classification Rationale
Class II.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190499 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | Sep 6, 2019 | SESE |
| K191252 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | Jul 9, 2019 | SESE |
| K143589 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | Jan 16, 2015 | SESE |
| K142309 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | Sep 16, 2014 | SESE |
| K132727 | GEM FLOW COUPLER DEVICE AND SYSTEM | Synovis Life Technologies, Inc. | Oct 22, 2013 | SESE |
| K093310 | GEM FLOW COUPLER DEVICE AND SYSTEM | Synovis Micro Companies Alliance, Inc. | Feb 1, 2010 | SESE |
| K090679 | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM | Vioptix, Inc. | Apr 17, 2009 | SESE |
| K040163 | MICROVASCULAR ANASTOMOTIC DEVICE | Synovis Micro Companies Alliance, Inc. | Apr 16, 2004 | SESE |
| K861985 | 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) | 3M Company | Dec 4, 1986 | SESE |
Top Applicants
- Synovis Life Technologies, Inc. — 3 clearances
- Synovis Micro Companies Alliance, Inc. — 2 clearances
- Baxter/ Synovis Micro Companies Alliance, Inc. — 2 clearances
- Vioptix, Inc. — 1 clearance
- 3M Company — 1 clearance
