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

    HEYER-SCHUTE UNIVERSAL URETERAL STENT

    K Number: K823418 · Decision Dec 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    56
    Review Days
    18

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    Basic Information

    Device Name
    HEYER-SCHUTE UNIVERSAL URETERAL STENT
    K Number
    K823418
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    American Hospital Supply Corp.
    Date Received
    November 15, 1982
    Decision Date
    December 3, 1982
    Product Code
    LJE
    Advisory Committee
    Unknown
    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
    LJE Catheter, Nephrostomy

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    K830343 CONTAINER W/PRIMING SOLUTION
    K830301 STRATUS FLUOROMETRIC ENZYME IMMUN0-
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