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FDA 510(k)

VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED

K-Number: K944221 · 1994-12-15

ApplicantCryosurgery, Inc.
Decision Date1994-12-15
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Cryosurgery, Inc.. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K944221. 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(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED?

VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Cryosurgery, Inc.. The 510(k) number is K944221.

When did VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED receive FDA 510(k) clearance?

VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED received FDA 510(k) clearance on 1994-12-15, under 510(k) number K944221.

Who is the listed applicant for VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED?

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(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED?

The FDA product code for VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED is GEH.

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Other records listing Cryosurgery, Inc. as applicant

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K261684FreezeSpray TAK253000CryoFreeze Wart and Skin Tag RemoverK252903Verruca-Freeze H PlusK243487CryoFreeze Wart and Skin Tag RemoverK243454Verruca-Freeze HK233347Verruca-Freeze® H

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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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix 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.

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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