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

    ASLAN SENSOR MODULAR INSTRUMENT

    K Number: K982287 · Decision Aug 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    37

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    Basic Information

    Device Name
    ASLAN SENSOR MODULAR INSTRUMENT
    K Number
    K982287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aslan Medical Technologies, Ltd.
    Date Received
    June 30, 1998
    Decision Date
    August 6, 1998
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Aslan Medical Technologies, Ltd.

    K Number Device Name
    K954864 ASLAN MODULAR INSTRUMENT
    K952264 ASLAN LAPRETRACT
    K950924 ASLAN KNOT PUSHER
    K944082 ASLAN DUAL ACTION JAWS GRASPING FORCEPS
    K926282 MCKERNAN-POTTS GRASPING FORCEPS
    K926281 MCKERNAN-ADSON AGGRESSIVE FORCEPS
    K925041 MCKERNAN ATRAUMATIC FORCEPS