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

    SURGITEK PERCUTANEOUS NEPHROSTOMY CATH

    K Number: K830226 · Decision Feb 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    28
    Review Days
    16

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    Basic Information

    Device Name
    SURGITEK PERCUTANEOUS NEPHROSTOMY CATH
    K Number
    K830226
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Medical Engineering Corp.
    Date Received
    January 24, 1983
    Decision Date
    February 9, 1983
    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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    K902773 SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET
    K884746 SURGITEK FLAT T-SPAN
    K883274 SURGITEK (R) UROFLOW SYSTEM
    K881736 SURGITEK CO2 DELIVERY SYSTEM
    K880802 SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
    K880801 SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
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