FDA 510(k)

DURAMESH Mesh Suture

Número K: K211178 · 2022-09-02

RequerenteMsi

Data da decisão2022-09-02

Código do produtoGAW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DURAMESH Mesh Suture is the device name listed in this FDA 510(k) record. The listed applicant is Msi. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K211178. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DURAMESH Mesh Suture?

DURAMESH Mesh Suture is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Msi. The 510(k) number is K211178.

When did DURAMESH Mesh Suture receive FDA 510(k) clearance?

DURAMESH Mesh Suture received FDA 510(k) clearance on 2022-09-02, under 510(k) number K211178.

Who is the listed applicant for DURAMESH Mesh Suture?

The FDA 510(k) record lists Msi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURAMESH Mesh Suture?

The FDA product code for DURAMESH Mesh Suture is GAW.

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