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

    SURGITEK SIZER FOR PENILE PROSTHESIS

    K Number: K830917 · Decision Apr 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    31
    Applicant Total
    28
    Review Days
    21

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    Basic Information

    Device Name
    SURGITEK SIZER FOR PENILE PROSTHESIS
    K Number
    K830917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.3630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Engineering Corp.
    Date Received
    March 22, 1983
    Decision Date
    April 12, 1983
    Product Code
    FAE
    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
    FAE Prosthesis, Penile

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    Other Clearances by Medical Engineering Corp.

    K Number Device Name
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    K903448 SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER
    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
    K842748 SURGITEK RECONSTRUC-NIPPLE PROSTHESIS
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