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

    H-H SEXTON SCUP URINE MGMT. SYS

    K Number: K853458 · Decision Aug 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    42
    Review Days
    11

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    Basic Information

    Device Name
    H-H SEXTON SCUP URINE MGMT. SYS
    K Number
    K853458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Holter-Hausner Intl.
    Date Received
    August 16, 1985
    Decision Date
    August 27, 1985
    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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    Other Clearances by Holter-Hausner Intl.

    K Number Device Name
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    K872285 H-H HUNTER ACTIVE TENDON IMPLANT DC
    K872284 H-H HUNTER ACTIVE TENDON IMPLANT PC
    K872293 H-H HUNTER ACTIVE TENDON IMPLANT BC
    K871351 H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
    K870660 H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
    K865075 H-H SUBGALEAL TROCAR
    K853436 H-H HUNTER PASSIVE TENDON IMPLANT
    K853437 H-H HUNTER TENDON ROD
    Search all 42 clearances from Holter-Hausner Intl. →