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

    RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER

    K Number: K962472 · Decision Aug 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    43
    Review Days
    63

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    Basic Information

    Device Name
    RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
    K Number
    K962472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rusch Intl.
    Date Received
    June 25, 1996
    Decision Date
    August 27, 1996
    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 Rusch Intl.

    K Number Device Name
    K033023 INTERMITTENT URETHRAL CATHETERS
    K030559 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
    K023666 RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
    K023918 RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
    K023964 RUSCH MICROLARYNGEAL TUBE
    K021540 RUSCH EDGAR TUBE
    K021764 RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
    K020714 RUSCH FLONEIL; FLOCATH INTROGEL
    K010798 RUSCH CANTOR TUBE
    K010797 RUSCH MILLER-ABBOTT TUBE
    Search all 43 clearances from Rusch Intl. →