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

    MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST

    K Number: K962273 · Decision Jul 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    28
    Applicant Total
    28
    Review Days
    48

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    Basic Information

    Device Name
    MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
    K Number
    K962273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marlo Surgical Technology
    Date Received
    June 13, 1996
    Decision Date
    July 31, 1996
    Product Code
    MFD
    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
    MFD Cannula, Intrauterine Insemination

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    Other Clearances by Marlo Surgical Technology

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    K924611 IRRIGATION PUMP AND TUBING SET
    K932634 NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES
    K932832 PRIMUS INSULATED FORCEPS
    K920611 MARLOW LAPAROSCOPIC GRASPING FORCEP
    K914153 OTT INSUFFLATOR FILTER PLUS/TUBING SET
    K914869 MARLOW LAPAROSCOPIC SCISSORS
    K913954 MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS
    K914872 MARLOW SUCTION/IRRIGATION PROBES
    K913964 MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS
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