Gem Flow Coupler Device and System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132727 FDA 510(k)
- FDA Product Code
- MVR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gem Flow Coupler Device and System is a microvascular anastomotic device used for connecting blood vessels during surgical procedures. It is designed to facilitate the anastomosis of small vessels in reconstructive and plastic surgery.
The device is supplied as a system for use in clinical settings and is intended for single-use applications. It has received FDA 510(k) clearance (K132727) and is classified as a Class II medical device under regulation number 878.4300 with product code MVR.
Frequently asked questions
What is the Gem Flow Coupler Device and System used for?
The Gem Flow Coupler Device and System is used for connecting blood vessels during surgical procedures, specifically designed to facilitate the anastomosis of small vessels in reconstructive and plastic surgery.
Is the Gem Flow Coupler Device and System intended for single-use or reuse?
The device is supplied as a system for use in clinical settings and is intended for single-use applications, meaning it is designed to be used once and then discarded to ensure patient safety and device integrity.
What regulatory pathway was used for the Gem Flow Coupler Device and System?
The Gem Flow Coupler Device and System received FDA 510(k) clearance under submission number K132727, indicating it was found substantially equivalent to a legally marketed predicate device.
How is the Gem Flow Coupler Device and System supplied?
The device is supplied as a complete system for use in clinical settings, containing all necessary components for performing microvascular anastomosis procedures in a sterile, ready-to-use format for single-use application.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132727 | Class II | Active |
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Manufacturer
- Manufacturer
- Synovis Life Technologies, Inc.
Sources (1)
- FDA 510(k) K132727 24 fields · synced Sep 23, 2026