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

    SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

    K Number: K053436 · Decision Jan 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    6
    Review Days
    35

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    Basic Information

    Device Name
    SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
    K Number
    K053436
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryocath Technologies, Inc.
    Date Received
    December 9, 2005
    Decision Date
    January 13, 2006
    Product Code
    OCL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

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    Other Clearances by Cryocath Technologies, Inc.

    K Number Device Name
    K081049 FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
    K070357 FLEXCATH STEERABLE SHEATH & DILATOR
    K062140 SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1
    K040690 SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
    K030303 FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE