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FDA 510(k)

TIGR Matrix Surgical Mesh

K-Number: K163005 · 2017-07-27

ApplicantNovus Scientific AB
Decision Date2017-07-27
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TIGR Matrix Surgical Mesh is a medical device manufactured by Novus Scientific AB. It received FDA 510(k) clearance on 2017-07-27 under approval number K163005. 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 TIGR Matrix Surgical Mesh?

TIGR Matrix Surgical Mesh is a medical device that received FDA 510(k) clearance on 2017-07-27. It is manufactured by Novus Scientific AB. The 510(k) number is K163005.

When was TIGR Matrix Surgical Mesh approved by the FDA?

TIGR Matrix Surgical Mesh received FDA 510(k) clearance on 2017-07-27, under approval number K163005.

What company makes TIGR Matrix Surgical Mesh?

TIGR Matrix Surgical Mesh is manufactured by Novus Scientific AB.

What is the FDA product code for TIGR Matrix Surgical Mesh?

The FDA product code for TIGR Matrix Surgical Mesh is OWT.

Related Clinical Trials

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Other Devices by Novus Scientific AB

K191749TIGR Matrix Surgical Mesh, TIGR Surgical Mesh

Related Devices (Code: OWT)

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 K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production 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.

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