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

    ENDOCARE CRYOTHERAPY SYSTEM

    K Number: K942299 · Decision Jan 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    7
    Review Days
    252

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    Basic Information

    Device Name
    ENDOCARE CRYOTHERAPY SYSTEM
    K Number
    K942299
    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
    Cytocare, Inc.
    Date Received
    May 12, 1994
    Decision Date
    January 19, 1995
    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 Cytocare, Inc.

    K Number Device Name
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    K952587 ENDOCARE MONOPOLAR ELECTRODES
    K945054 ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM
    K934211 CYTOCARE DIODE LASER SYSTEM
    K921708 CYTOCARE LASER CATHETER FOR UROLOGY