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 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.

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. 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.

Related Devices (Code: GAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris Medical K230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC K193530Deklene MAXXTeleflex Medical

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.