Phasix ST Umbilical Hernia Patch
K-Number: K243241 · 2025-02-19
Decision Date2025-02-19
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Phasix ST Umbilical Hernia Patch is a medical device manufactured by Davol, Inc., A Subsidiary of C.R. Bard, Inc.. It received FDA 510(k) clearance on 2025-02-19 under approval number K243241. 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 Umbilical Hernia Patch?
Phasix ST Umbilical Hernia Patch is a medical device that received FDA 510(k) clearance on 2025-02-19. It is manufactured by Davol, Inc., A Subsidiary of C.R. Bard, Inc.. The 510(k) number is K243241.
When was Phasix ST Umbilical Hernia Patch approved by the FDA?
Phasix ST Umbilical Hernia Patch received FDA 510(k) clearance on 2025-02-19, under approval number K243241.
What company makes Phasix ST Umbilical Hernia Patch?
Phasix ST Umbilical Hernia Patch is manufactured by Davol, Inc., A Subsidiary of C.R. Bard, Inc..
What is the FDA product code for Phasix ST Umbilical Hernia Patch?
The FDA product code for Phasix ST Umbilical Hernia Patch is OWT.
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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.