BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CRYOGEN CRYOSURGICAL SYSTEM

    K Number: K964971 · Decision Mar 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    4
    Review Days
    106

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    Basic Information

    Device Name
    CRYOGEN CRYOSURGICAL SYSTEM
    K Number
    K964971
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cryogen, Inc.
    Date Received
    December 12, 1996
    Decision Date
    March 28, 1997
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by Cryogen, Inc.

    K Number Device Name
    K003050 CRYOSURGICAL UNIT AND ACCESSORIES
    K974320 CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
    K972662 CRYOGEN CRYOSURGICAL SYSTEM