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

    HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878

    K Number: K926570 · Decision May 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    85
    Review Days
    141

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    Basic Information

    Device Name
    HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
    K Number
    K926570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hollister, Inc.
    Date Received
    December 31, 1992
    Decision Date
    May 21, 1993
    Product Code
    KNX
    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
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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    K050483 EVADRI BLADDER CONTROL SYSTEMS
    K040779 RESTORE WOUND CLEANSER
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    K013483 INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT
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