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FDA 510(k)

CRYOFOS

K-Number: K170810 · 2017-09-27

ApplicantCryofos Medical GmbH
Decision Date2017-09-27
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOFOS is the device name listed in this FDA 510(k) record. The listed applicant is Cryofos Medical GmbH. It received FDA 510(k) clearance on 2017-09-27 under 510(k) number K170810. 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 CRYOFOS?

CRYOFOS is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is Cryofos Medical GmbH. The 510(k) number is K170810.

When did CRYOFOS receive FDA 510(k) clearance?

CRYOFOS received FDA 510(k) clearance on 2017-09-27, under 510(k) number K170810.

Who is the listed applicant for CRYOFOS?

The FDA 510(k) record lists Cryofos Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOFOS?

The FDA product code for CRYOFOS 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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