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

    SCLEROTHERAPY NEEDLE

    K Number: K914496 · Decision Dec 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    11
    Review Days
    58

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    Basic Information

    Device Name
    SCLEROTHERAPY NEEDLE
    K Number
    K914496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgitek Medical Engineering Corp.
    Date Received
    October 8, 1991
    Decision Date
    December 5, 1991
    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 Surgitek Medical Engineering Corp.

    K Number Device Name
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    K914505 STONE BASKET
    K914503 GRASPING FORCEPS
    K913928 SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT
    K913294 SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
    K910769 SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
    K910768 SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
    K903127 SURGITEK(R) TURP MONITOR
    Search all 11 clearances from Surgitek Medical Engineering Corp. →