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FDA 510(k)

Focused Cryotherapy System

K-Number: K250742 · 2025-12-09

ApplicantFocused Cryo, Inc.
Decision Date2025-12-09
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Focused Cryotherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Focused Cryo, Inc.. It received FDA 510(k) clearance on 2025-12-09 under 510(k) number K250742. 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 Focused Cryotherapy System?

Focused Cryotherapy System is a medical device that received FDA 510(k) clearance on 2025-12-09. The listed applicant is Focused Cryo, Inc.. The 510(k) number is K250742.

When did Focused Cryotherapy System receive FDA 510(k) clearance?

Focused Cryotherapy System received FDA 510(k) clearance on 2025-12-09, under 510(k) number K250742.

Who is the listed applicant for Focused Cryotherapy System?

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

What is the FDA product code for Focused Cryotherapy System?

The FDA product code for Focused Cryotherapy System 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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