FDA 510(k)

Transorb Self-Gripping Resorbable Mesh

K-Number: K233661 · 2024-02-13

Decision Date2024-02-13

Product CodeOWT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Transorb Self-Gripping Resorbable Mesh is a medical device manufactured by Sofradim Production. It received FDA 510(k) clearance on 2024-02-13 under approval number K233661. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transorb Self-Gripping Resorbable Mesh?

Transorb Self-Gripping Resorbable Mesh is a medical device that received FDA 510(k) clearance on 2024-02-13. It is manufactured by Sofradim Production. The 510(k) number is K233661.

When was Transorb Self-Gripping Resorbable Mesh approved by the FDA?

Transorb Self-Gripping Resorbable Mesh received FDA 510(k) clearance on 2024-02-13, under approval number K233661.

What company makes Transorb Self-Gripping Resorbable Mesh?

Transorb Self-Gripping Resorbable Mesh is manufactured by Sofradim Production.

What is the FDA product code for Transorb Self-Gripping Resorbable Mesh?

The FDA product code for Transorb Self-Gripping Resorbable Mesh is OWT.

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Related Devices (Code: OWT)

K163005TIGR Matrix Surgical MeshNovus Scientific AB K173143Phasix ST MeshC.R. Bard, Inc. K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc. K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, 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.