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FDA 510(k)

Phasix ST Mesh with Open Positioning System

K-Number: K190185 · 2019-06-12

ApplicantC.R. Bard, Inc.
Decision Date2019-06-12
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Phasix ST Mesh with Open Positioning System is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-06-12 under approval number K190185. 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 Phasix ST Mesh with Open Positioning System?

Phasix ST Mesh with Open Positioning System is a medical device that received FDA 510(k) clearance on 2019-06-12. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K190185.

When was Phasix ST Mesh with Open Positioning System approved by the FDA?

Phasix ST Mesh with Open Positioning System received FDA 510(k) clearance on 2019-06-12, under approval number K190185.

What company makes Phasix ST Mesh with Open Positioning System?

Phasix ST Mesh with Open Positioning System is manufactured by C.R. Bard, Inc..

What is the FDA product code for Phasix ST Mesh with Open Positioning System?

The FDA product code for Phasix ST Mesh with Open Positioning System 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. 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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