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

    COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH

    K Number: K942573 · Decision Jul 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    8
    Review Days
    48

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    Basic Information

    Device Name
    COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH
    K Number
    K942573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Richard Hamer Assoc., Inc.
    Date Received
    May 31, 1994
    Decision Date
    July 18, 1994
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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    Other Clearances by Richard Hamer Assoc., Inc.

    K Number Device Name
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    K950934 MPM HYDROGEL DRESSING
    K951327 COMFEEL PLUS CONTOUR DRESSING
    K942283 COMFEEL PLUS TRANSPARENT DRESSING
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    K934839 MESALT STERILE DRESSING