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FDA 510(k)

CRYOSURGICAL DEVICE 2000

K-Number: K781956 · 1979-01-10

ApplicantValleylab, Inc.
Decision Date1979-01-10
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOSURGICAL DEVICE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 1979-01-10 under 510(k) number K781956. 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 CRYOSURGICAL DEVICE 2000?

CRYOSURGICAL DEVICE 2000 is a medical device that received FDA 510(k) clearance on 1979-01-10. The listed applicant is Valleylab, Inc.. The 510(k) number is K781956.

When did CRYOSURGICAL DEVICE 2000 receive FDA 510(k) clearance?

CRYOSURGICAL DEVICE 2000 received FDA 510(k) clearance on 1979-01-10, under 510(k) number K781956.

Who is the listed applicant for CRYOSURGICAL DEVICE 2000?

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

What is the FDA product code for CRYOSURGICAL DEVICE 2000?

The FDA product code for CRYOSURGICAL DEVICE 2000 is GEH.

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Related Devices (Code: GEH)

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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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