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 a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2018-04-25 under approval 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. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K173143.
When was Phasix ST Mesh approved by the FDA?
Phasix ST Mesh received FDA 510(k) clearance on 2018-04-25, under approval number K173143.
What company makes Phasix ST Mesh?
Phasix ST Mesh is manufactured by C.R. Bard, Inc..
What is the FDA product code for Phasix ST Mesh?
The FDA product code for Phasix ST Mesh is OWT.
Other Devices by C.R. Bard, Inc.
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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.