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FDA 510(k)

ChitoZolve

K-Number: K181696 · 2018-11-30

ApplicantGyrus Acmi, Inc.
Decision Date2018-11-30
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ChitoZolve is a medical device manufactured by Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2018-11-30 under approval number K181696. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ChitoZolve?

ChitoZolve is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Gyrus Acmi, Inc.. The 510(k) number is K181696.

When was ChitoZolve approved by the FDA?

ChitoZolve received FDA 510(k) clearance on 2018-11-30, under approval number K181696.

What company makes ChitoZolve?

ChitoZolve is manufactured by Gyrus Acmi, Inc..

What is the FDA product code for ChitoZolve?

The FDA product code for ChitoZolve is LYA.

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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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