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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 the device name listed in this FDA 510(k) record. The listed applicant is Brymill Cryogenic Systems. It received FDA 510(k) clearance on 2020-03-25 under 510(k) 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. The listed applicant is Brymill Cryogenic Systems. The 510(k) number is K193619.

When did Cry-Ac®, Cry-Ac-3®, Cry-Baby receive FDA 510(k) clearance?

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

Who is the listed applicant for Cry-Ac®, Cry-Ac-3®, Cry-Baby?

The FDA 510(k) record lists Brymill Cryogenic Systems as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: GEH)

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.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

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.

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