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

    ACUCISE URETERAL CUTTING CATHETER

    K Number: K921838 · Decision Feb 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    27
    Applicant Total
    13
    Review Days
    315

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    Basic Information

    Device Name
    ACUCISE URETERAL CUTTING CATHETER
    K Number
    K921838
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Urology, Inc.
    Date Received
    April 17, 1992
    Decision Date
    February 26, 1993
    Product Code
    EYB
    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
    EYB Catheter, Ureteral, Gastro-Urology

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    Other Clearances by Applied Urology, Inc.

    K Number Device Name
    K925282 UROLOGICAL CATHETER AND ACCESSORIES
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    K912093 DISPOSABLE ASPIRATION IRRIGATION SYSTEM
    K920030 SURESEAL ENDOSCOPIC VALVE
    K912656 ENDOSCOPIC ELECTRODE
    K912903 PERCUTANEOUS RETRACTOR KIT
    K905731 FLEXIBLE ENDOSCOPIC ELECTRODE
    K903994 URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION
    K901214 RIGID URETEROSCOPE
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