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

    E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS

    K Number: K841720 · Decision Jul 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    56
    Review Days
    92

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    Basic Information

    Device Name
    E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS
    K Number
    K841720
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    E-Z-Em, Inc.
    Date Received
    April 25, 1984
    Decision Date
    July 26, 1984
    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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    Other Clearances by E-Z-Em, Inc.

    K Number Device Name
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    K063029 EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
    K053008 E-Z-EM ENDOSCOPIC CO2 REGULATOR
    K041178 EMPOWER TRANSFER SET, (CAT. NO. 7725)
    K031571 EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
    K030854 PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
    K013219 PROTOCO2L INSUFFLATOR MODEL 6400
    K011160 E-Z EM PERCUPUMP 2001 CT INJECTOR
    K974621 PERCUPUMP II WITH EDA
    Search all 56 clearances from E-Z-Em, Inc. →