FDA 510(k)

GEM Biover Microvascular Clamps

K-Number: K221843 · 2022-09-14

ApplicantSynovis Micro Companies Alliance, Inc.

Decision Date2022-09-14

Product CodeDXC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GEM Biover Microvascular Clamps is a medical device manufactured by Synovis Micro Companies Alliance, Inc.. It received FDA 510(k) clearance on 2022-09-14 under approval number K221843. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM Biover Microvascular Clamps?

GEM Biover Microvascular Clamps is a medical device that received FDA 510(k) clearance on 2022-09-14. It is manufactured by Synovis Micro Companies Alliance, Inc.. The 510(k) number is K221843.

When was GEM Biover Microvascular Clamps approved by the FDA?

GEM Biover Microvascular Clamps received FDA 510(k) clearance on 2022-09-14, under approval number K221843.

What company makes GEM Biover Microvascular Clamps?

GEM Biover Microvascular Clamps is manufactured by Synovis Micro Companies Alliance, Inc..

What is the FDA product code for GEM Biover Microvascular Clamps?

The FDA product code for GEM Biover Microvascular Clamps is DXC.

Other Devices by Synovis Micro Companies Alliance, Inc.

K213974GEM FLOW COUPLER Monitor (GEM1020M-2)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.