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

    SOFTSEAL HSG CATHETER

    K Number: K040238 · Decision Jun 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    86
    Applicant Total
    14
    Review Days
    148

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    Basic Information

    Device Name
    SOFTSEAL HSG CATHETER
    K Number
    K040238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Modern Medical Equipment Mfg., Ltd.
    Date Received
    January 26, 2004
    Decision Date
    June 22, 2004
    Product Code
    LKF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKF Cannula, Manipulator/Injector, Uterine

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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
    K032327 MODERN MEDICAL BIPOLAR FORCEPS
    K030831 LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
    K033003 SUCTION COAGULATOR
    Search all 14 clearances from Modern Medical Equipment Mfg., Ltd. →