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

    MARTECH ENDOSCOPIC INJECTION NEEDLE

    K Number: K960519 · Decision May 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    7
    Review Days
    86

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    Basic Information

    Device Name
    MARTECH ENDOSCOPIC INJECTION NEEDLE
    K Number
    K960519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Martech Medical Products, Inc.
    Date Received
    February 5, 1996
    Decision Date
    May 1, 1996
    Product Code
    FBK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

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    Other Clearances by Martech Medical Products, Inc.

    K Number Device Name
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    K922438 PRO2 OXYGEN ANALYZER
    K926007 ACCESSORY TO PISTON SYRINGE
    K914778 NEOLINE(TM)
    K910970 MARKSMAN ARTERIAL BLOOD GAS SYRINGE
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