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FDA 510(k)

CRYOGEN CRYOSURGICAL SYSTEM

K-Number: K964971 · 1997-03-28

ApplicantCryogen, Inc.
Decision Date1997-03-28
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOGEN CRYOSURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cryogen, Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K964971. 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 CRYOGEN CRYOSURGICAL SYSTEM?

CRYOGEN CRYOSURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Cryogen, Inc.. The 510(k) number is K964971.

When did CRYOGEN CRYOSURGICAL SYSTEM receive FDA 510(k) clearance?

CRYOGEN CRYOSURGICAL SYSTEM received FDA 510(k) clearance on 1997-03-28, under 510(k) number K964971.

Who is the listed applicant for CRYOGEN CRYOSURGICAL SYSTEM?

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

What is the FDA product code for CRYOGEN CRYOSURGICAL SYSTEM?

The FDA product code for CRYOGEN CRYOSURGICAL SYSTEM is GEH.

Related Clinical Trials

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.

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Other records listing Cryogen, 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.

K003050CRYOSURGICAL UNIT AND ACCESSORIESK974320CRYOGEN CARDIAC CRYOSURGICAL SYSTEMK972662CRYOGEN CRYOSURGICAL SYSTEM

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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