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FDA 510(k)

DURAMESH Mesh Suture

K-Number: K211178 · 2022-09-02

ApplicantMsi
Decision Date2022-09-02
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DURAMESH Mesh Suture is a medical device manufactured by Msi. It received FDA 510(k) clearance on 2022-09-02 under approval number K211178. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURAMESH Mesh Suture?

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

When was DURAMESH Mesh Suture approved by the FDA?

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

What company makes DURAMESH Mesh Suture?

DURAMESH Mesh Suture is manufactured by Msi.

What is the FDA product code for DURAMESH Mesh Suture?

The FDA product code for DURAMESH Mesh Suture is GAW.

Related Clinical Trials

NCT06511414 Effect of Duramesh™ on Hernia Formation After Ileostomy Closure ACTIVE_NOT_RECRUITING

Related Devices (Code: GAW)

K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions K171039Assut Filbloc Permanent SuturesAssut Europe S.P.A. K171005Silhouette FeatherliftSilhouette Lift, Inc. K162617NobleStitch ELNobles Medical Technologies Ii, Inc. K173747REXLENESm Eng Co., Ltd. K180321Aesculap Optilene Nonabsorbable SutureAesculap, Inc.

Official Source

View on FDA Database →

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

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