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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 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 2016-09-29 under 510(k) 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. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K161424.

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

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

Who is the listed applicant for Phasix 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 Mesh?

The FDA product code for Phasix Mesh is OOD.

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Related Devices (Code: OOD)

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.

K233999GalaFLEX LITE ScaffoldTepha, Inc.K202425SurgiLattice scaffoldTepha, Inc.K162922GalaFORM 3DTepha, Inc.K161092GalaSHAPE 3DTepha, 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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