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FDA 510(k)

Phasix ST Mesh with Echo 2 Positioning System

K-Number: K182008 · 2018-12-14

ApplicantC.R. Bard, Inc.
Decision Date2018-12-14
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Phasix ST Mesh with Echo 2 Positioning System is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2018-12-14 under approval number K182008. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phasix ST Mesh with Echo 2 Positioning System?

Phasix ST Mesh with Echo 2 Positioning System is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K182008.

When was Phasix ST Mesh with Echo 2 Positioning System approved by the FDA?

Phasix ST Mesh with Echo 2 Positioning System received FDA 510(k) clearance on 2018-12-14, under approval number K182008.

What company makes Phasix ST Mesh with Echo 2 Positioning System?

Phasix ST Mesh with Echo 2 Positioning System is manufactured by C.R. Bard, Inc..

What is the FDA product code for Phasix ST Mesh with Echo 2 Positioning System?

The FDA product code for Phasix ST Mesh with Echo 2 Positioning System is FTL.

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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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