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FDA 510(k)

Phasix ST Mesh

K-Number: K173143 · 2018-04-25

ApplicantC.R. Bard, Inc.
Decision Date2018-04-25
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Phasix ST Mesh is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2018-04-25 under 510(k) number K173143. 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?

Phasix ST Mesh is a medical device that received FDA 510(k) clearance on 2018-04-25. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K173143.

When did Phasix ST Mesh receive FDA 510(k) clearance?

Phasix ST Mesh received FDA 510(k) clearance on 2018-04-25, under 510(k) number K173143.

Who is the listed applicant for Phasix ST Mesh?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phasix ST Mesh?

The FDA product code for Phasix ST Mesh is OWT.

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Other records listing C.R. Bard, Inc. as applicant

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Related Devices (Code: OWT)

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.

K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.K233661Transorb™ Self-Gripping Resorbable MeshSofradim ProductionK191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific ABK191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.K163005TIGR Matrix Surgical MeshNovus Scientific AB

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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