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

    SURGICAL MEDICAL DEVICE CAUTERY

    K Number: K023506 · Decision Jan 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    23
    Applicant Total
    14
    Review Days
    452

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    Basic Information

    Device Name
    SURGICAL MEDICAL DEVICE CAUTERY
    K Number
    K023506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Modern Medical Equipment Mfg., Ltd.
    Date Received
    October 18, 2002
    Decision Date
    January 13, 2004
    Product Code
    HQP
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQP Unit, Cautery, Thermal, Battery-Powered

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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. →