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

    PERSONAL PUNCH

    K Number: K870136 · Decision Apr 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    101
    Applicant Total
    2
    Review Days
    78

    Basic Information

    Device Name
    PERSONAL PUNCH
    K Number
    K870136
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5900
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Arnold Technologies
    Date Received
    January 13, 1987
    Decision Date
    April 1, 1987
    Product Code
    EXB
    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
    EXB Collector, Ostomy

    Similar 510(k) Clearances

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

    Heylo™ System

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

    SmartBag (SmartPouch)

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

    OSTOM-I ALERT

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

    LAKE OSTOMY CARE SET

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

    ODOR-END EMERGENCY CLEAN UP POWDER

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

    CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)

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

    Other Clearances by Arnold Technologies

    K Number Device Name
    K872294 COMBINATION NITE DRAINAGE UNIT