FDA 510(k)

GEM Biover Microvascular Clamps

Número K: K221843 · 2022-09-14

RequerenteSynovis Micro Companies Alliance, Inc.

Data da decisão2022-09-14

Código do produtoDXC

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Synovis Micro Companies Alliance, Inc.. The 510(k) number is K221843.

When did GEM Biover Microvascular Clamps receive FDA 510(k) clearance?

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

Who is the listed applicant for GEM Biover Microvascular Clamps?

The FDA 510(k) record lists Synovis Micro Companies Alliance, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Fonte oficial

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