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

    MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN

    K Number: K850129 · Decision Feb 28, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    15
    Review Days
    45

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    Basic Information

    Device Name
    MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN
    K Number
    K850129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Consolidated Medical Equipment, Inc.
    Date Received
    January 14, 1985
    Decision Date
    February 28, 1985
    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 Consolidated Medical Equipment, Inc.

    K Number Device Name
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    K850037 CLOSED WOUND DRAIN
    K844942 PLURA-GARD CHEST DRAINAGE SYSTEM
    K850311 DISPOS. CONDUCTIVE ADHESIVE TENS PAD
    K850131 CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS
    K850133 VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
    K844372 HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE
    K844371 HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE
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