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

    URETERAL STENT

    K Number: K930733 · Decision Jul 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    29
    Review Days
    162

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    Basic Information

    Device Name
    URETERAL STENT
    K Number
    K930733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgitek
    Date Received
    February 11, 1993
    Decision Date
    July 23, 1993
    Product Code
    FAD
    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
    FAD Stent, Ureteral

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    Other Clearances by Surgitek

    K Number Device Name
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    K944391 OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
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    K941952 SURGITEK INFUSER
    K933261 GRASPING FORCEPS
    K933260 HELICAL STONE/FLATWIRE STONE BASKETS
    K930483 URETERAL CATHETER
    K926344 HYDROPHILIC COATED GUIDEWIRE
    K920451 ENDOTEK ULTRA SYSTEM
    K922542 GRASPING FORCEPS
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