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

    ENDOCARE ELECTROSURGICAL HANDPIECE

    K Number: K952698 · Decision Aug 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    7
    Review Days
    62

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    Basic Information

    Device Name
    ENDOCARE ELECTROSURGICAL HANDPIECE
    K Number
    K952698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cytocare, Inc.
    Date Received
    June 13, 1995
    Decision Date
    August 14, 1995
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Cytocare, Inc.

    K Number Device Name
    K954321 ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)
    K952587 ENDOCARE MONOPOLAR ELECTRODES
    K942299 ENDOCARE CRYOTHERAPY SYSTEM
    K945054 ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM
    K934211 CYTOCARE DIODE LASER SYSTEM
    K921708 CYTOCARE LASER CATHETER FOR UROLOGY