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

    SURGITEK CO2 DELIVERY SYSTEM

    K Number: K881736 · Decision Aug 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    28
    Review Days
    111

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    Basic Information

    Device Name
    SURGITEK CO2 DELIVERY SYSTEM
    K Number
    K881736
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Engineering Corp.
    Date Received
    April 22, 1988
    Decision Date
    August 11, 1988
    Product Code
    FAP
    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
    FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

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    Other Clearances by Medical Engineering Corp.

    K Number Device Name
    K934141 STAND ALONE CYSTOMETROGRAM
    K905289 SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
    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
    K880802 SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
    K880801 SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
    K842748 SURGITEK RECONSTRUC-NIPPLE PROSTHESIS
    K832043 SURGIKEK PENILE PROSTHESIS TAIL EXTEND
    Search all 28 clearances from Medical Engineering Corp. →