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

    ADVANCED UROSCIENCE INNERSHEATH

    K Number: K002573 · Decision Nov 16, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    ADVANCED UROSCIENCE INNERSHEATH
    K Number
    K002573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Uroscience, Inc.
    Date Received
    August 18, 2000
    Decision Date
    November 16, 2000
    Product Code
    FBK
    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
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

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    Other Clearances by Advanced Uroscience, Inc.

    K Number Device Name
    K001807 TISSUE MARKER
    K002323 ADVANCED UROSCIENCE INJECTION NEEDLE
    K993459 MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    K982890 ADVANCED UROSCIENCE INJECTION NEEDLE