Microvascular Anastomotic Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040163 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 Microvascular Anastomotic Coupler is a device classified as an anastomotic, microvascular device, designed to facilitate the surgical connection (anastomosis) of blood vessels. It is intended for use with veins and arteries having an outside diameter ranging from 0.8 mm to 4.3 mm and a wall thickness of 0.5 mm or less. This device aids in microsurgical and vascular reconstructive procedures by providing a secure, efficient method for joining small-diameter vessels.
The Microvascular Anastomotic Coupler is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K040163) as substantially equivalent to a predicate device. It is intended for use in controlled surgical settings, such as operating rooms, and must be stored under appropriate conditions to maintain sterility. The device adheres to regulatory standards outlined in 21 CFR 878.4300 and is categorized under device class II. No third-party certification beyond FDA clearance is indicated in the available data.
Frequently asked questions
What is the Microvascular Anastomotic Coupler used for?
This device is designed specifically for microsurgical and vascular reconstructive procedures to create secure anastomoses (connections) between blood vessels. It is intended for veins and arteries with an outside diameter ranging from 0.8 mm to 4.3 mm and a wall thickness of 0.5 mm or less. Its purpose is to simplify and improve the reliability of vessel connections during delicate surgical interventions.
Is the Microvascular Anastomotic Coupler reusable or single-use?
The Microvascular Anastomotic Coupler is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintaining sterility for each surgical procedure. Single-use devices are also designed to avoid degradation from repeated sterilization processes, which could compromise performance.
What vessel sizes can the Microvascular Anastomotic Coupler accommodate?
The device is engineered to connect vessels with an outside diameter between 0.8 mm and 4.3 mm, with a wall thickness of 0.5 mm or less. This range covers a broad spectrum of small arteries and veins commonly encountered in microsurgery, such as those in reconstructive or plastic surgery applications.
How should the Microvascular Anastomotic Coupler be stored to maintain sterility?
To preserve sterility, the device must be stored under controlled conditions as specified by the manufacturer. Typically, this involves keeping it in its original, sealed packaging away from direct sunlight, extreme temperatures, and moisture. Adherence to these storage guidelines ensures the device remains uncontaminated and ready for use in sterile surgical environments.
What regulatory pathway does the Microvascular Anastomotic Coupler follow?
The Microvascular Anastomotic Coupler is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K040163. It is classified as substantially equivalent to a predicate device and falls under device class II (21 CFR 878.4300). This pathway ensures the device meets established safety and effectiveness standards for microvascular anastomotic applications in surgical settings.
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. Sources consulted: Microvascular Anastomotic COUPLER - Synovis Micro Companies Alliance, Inc., Synovis Micro, Microvascular Anastomotic Coupler | Synovis Micro Companies Alliance, Inc., MICROVASCULAR ANASTOMOTIC DEVICE by SYNOVIS MICRO COMPANIES ALLIANCE ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040163 | Class II | Active |
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Manufacturer
- Manufacturer
- Synovis Micro Companies Alliance, Inc
- FDA Applicant
- Synovis Micro Companies Alliance, Inc.
Sources (1)
- FDA 510(k) K040163 24 fields · synced Oct 5, 2026