Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4300](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4300) → MVR — Device, Anastomotic, Microvascular

# MVR · Device, Anastomotic, Microvascular

_General, Plastic Surgery · 21 CFR 878.4300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR

## Overview

- **Product Code:** MVR
- **Device Name:** Device, Anastomotic, Microvascular
- **Regulation:** [21 CFR 878.4300](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4300)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR/K190499.md) | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | Sep 6, 2019 | SESE |
| [K191252](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR/K191252.md) | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | Jul 9, 2019 | SESE |
| [K143589](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR/K143589.md) | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | Jan 16, 2015 | SESE |
| [K142309](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR/K142309.md) | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | Sep 16, 2014 | SESE |
| [K132727](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR/K132727.md) | GEM FLOW COUPLER DEVICE AND SYSTEM | Synovis Life Technologies, Inc. | Oct 22, 2013 | SESE |
| [K093310](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR/K093310.md) | GEM FLOW COUPLER DEVICE AND SYSTEM | Synovis Micro Companies Alliance, Inc. | Feb 1, 2010 | SESE |
| [K090679](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR/K090679.md) | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM | Vioptix, Inc. | Apr 17, 2009 | SESE |
| [K040163](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR/K040163.md) | MICROVASCULAR ANASTOMOTIC DEVICE | Synovis Micro Companies Alliance, Inc. | Apr 16, 2004 | SESE |
| [K861985](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR/K861985.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MVR)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com