BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UROTRACT I

    K Number: K955019 · Decision Dec 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    40
    Review Days
    34

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    UROTRACT I
    K Number
    K955019
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.4890
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dornier Medtech America, Inc.
    Date Received
    November 2, 1995
    Decision Date
    December 6, 1995
    Product Code
    KQS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KQS Table, Cystometric, Non-Electric And Accessories

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KQS), ordered by most recent decision date.

    UROVIEW

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    RADIOGRAPHIC - LEG SECTION

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    HYDRAJUST III UROLOGICAL TABLE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    AMSCO URO-ENDO MOBILE TABLE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    UR 150-UR 150T

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    HYDRADJUST II UROLOGICAL TABLE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology
    View all

    Other Clearances by Dornier Medtech America, Inc.

    K Number Device Name
    K221903 Delta III Pro
    K213252 Dornier Thulio
    K220871 Nautilus
    K210394 Electrosurgical accessory
    K201815 Dornier MAGELLAN Ureteral Access Sheath
    K201074 Delta III Lithotripter
    K190612 EQUINOX Balloon Dilatation Catheter
    K190312 Dornier Ureteral Stent
    K191187 Dornier MINNOW Ureteral Catheter
    K172084 Delta III Lithotripter
    Search all 40 clearances from Dornier Medtech America, Inc. →