FDA 510(k)

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal

K-Number: K182259 · 2019-02-07

Decision Date2019-02-07

Product CodeFTM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2019-02-07 under 510(k) number K182259. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal?

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is a medical device that received FDA 510(k) clearance on 2019-02-07. The listed applicant is Acell, Inc.. The 510(k) number is K182259.

When did Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal receive FDA 510(k) clearance?

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal received FDA 510(k) clearance on 2019-02-07, under 510(k) number K182259.

Who is the listed applicant for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal?

The FDA 510(k) record lists Acell, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal?

The FDA product code for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is FTM.

Other records listing Acell, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.