BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇰 Hong Kong

    LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE

    K Number: K032965 · Decision May 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    14
    Review Days
    233

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    Basic Information

    Device Name
    LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE
    K Number
    K032965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Modern Medical Equipment Mfg., Ltd.
    Date Received
    September 23, 2003
    Decision Date
    May 13, 2004
    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 Modern Medical Equipment Mfg., Ltd.

    K Number Device Name
    K093479 DISPOSABLE SUCTION AND IRRIGATION SYSTEM
    K091511 MODERN MEDICAL RESECTOSCOPE ELECTRODES
    K070812 DISPOSABLE LAPAROSCOPIC INSTRUMENT
    K070877 ENDOCERVICAL ELECTRODE # 2
    K050842 AGCEL WOUND DRESSING,AGCEL BURN DRESSING
    K043036 NON-STICK ELECTRODE
    K033095 SMOKE EVACUATION ATTACHEMENT
    K040238 SOFTSEAL HSG CATHETER
    K032327 MODERN MEDICAL BIPOLAR FORCEPS
    K030831 LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
    Search all 14 clearances from Modern Medical Equipment Mfg., Ltd. →