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FDA 510(k)

Cry-Ac®, Cry-Ac-3®, Cry-Baby

K-Number: K193619 · 2020-03-25

ApplicantBrymill Cryogenic Systems
Decision Date2020-03-25
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cry-Ac®, Cry-Ac-3®, Cry-Baby is a medical device manufactured by Brymill Cryogenic Systems. It received FDA 510(k) clearance on 2020-03-25 under approval number K193619. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cry-Ac®, Cry-Ac-3®, Cry-Baby?

Cry-Ac®, Cry-Ac-3®, Cry-Baby is a medical device that received FDA 510(k) clearance on 2020-03-25. It is manufactured by Brymill Cryogenic Systems. The 510(k) number is K193619.

When was Cry-Ac®, Cry-Ac-3®, Cry-Baby approved by the FDA?

Cry-Ac®, Cry-Ac-3®, Cry-Baby received FDA 510(k) clearance on 2020-03-25, under approval number K193619.

What company makes Cry-Ac®, Cry-Ac-3®, Cry-Baby?

Cry-Ac®, Cry-Ac-3®, Cry-Baby is manufactured by Brymill Cryogenic Systems.

What is the FDA product code for Cry-Ac®, Cry-Ac-3®, Cry-Baby?

The FDA product code for Cry-Ac®, Cry-Ac-3®, Cry-Baby is GEH.

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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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