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FDA 510(k)

Phasix Mesh

K-Number: K161424 · 2016-09-29

ApplicantC.R. Bard, Inc.
Decision Date2016-09-29
Product CodeOOD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Phasix Mesh is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-09-29 under approval number K161424. The device is classified under product code OOD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phasix Mesh?

Phasix Mesh is a medical device that received FDA 510(k) clearance on 2016-09-29. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K161424.

When was Phasix Mesh approved by the FDA?

Phasix Mesh received FDA 510(k) clearance on 2016-09-29, under approval number K161424.

What company makes Phasix Mesh?

Phasix Mesh is manufactured by C.R. Bard, Inc..

What is the FDA product code for Phasix Mesh?

The FDA product code for Phasix Mesh is OOD.

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Related Devices (Code: OOD)

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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.

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