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FDA 510(k)

Verruca-Freeze® H

K-Number: K233347 · 2023-12-04

ApplicantCryosurgery, Inc.
Decision Date2023-12-04
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Verruca-Freeze® H is the device name listed in this FDA 510(k) record. The listed applicant is Cryosurgery, Inc.. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K233347. 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 Verruca-Freeze® H?

Verruca-Freeze® H is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is Cryosurgery, Inc.. The 510(k) number is K233347.

When did Verruca-Freeze® H receive FDA 510(k) clearance?

Verruca-Freeze® H received FDA 510(k) clearance on 2023-12-04, under 510(k) number K233347.

Who is the listed applicant for Verruca-Freeze® H?

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

What is the FDA product code for Verruca-Freeze® H?

The FDA product code for Verruca-Freeze® H is GEH.

Other records listing Cryosurgery, Inc. as applicant

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.

K253000CryoFreeze Wart and Skin Tag RemoverK252903Verruca-Freeze H PlusK243487CryoFreeze Wart and Skin Tag RemoverK243454Verruca-Freeze H

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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