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FDA 510(k)

VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM

K-Number: K881349 · 1988-06-30

ApplicantCryosurg, Inc.
Decision Date1988-06-30
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cryosurg, Inc.. It received FDA 510(k) clearance on 1988-06-30 under 510(k) number K881349. 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) CRYOTHERAPY DELIVERY SYSTEM?

VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1988-06-30. The listed applicant is Cryosurg, Inc.. The 510(k) number is K881349.

When did VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM receive FDA 510(k) clearance?

VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM received FDA 510(k) clearance on 1988-06-30, under 510(k) number K881349.

Who is the listed applicant for VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM?

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

What is the FDA product code for VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM?

The FDA product code for VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM is GEH.

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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

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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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