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

    MALE EXTERNAL CATHETER

    K Number: K830946 · Decision Apr 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    6
    Review Days
    35

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    Basic Information

    Device Name
    MALE EXTERNAL CATHETER
    K Number
    K830946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Post Medical, Inc.
    Date Received
    March 24, 1983
    Decision Date
    April 28, 1983
    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 Post Medical, Inc.

    K Number Device Name
    K990371 DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
    K972536 SYRINGE NEEDLE REMOVER (S.N.R.)
    K925086 AUTOMATIC NEEDLE DISCONECT (A.N.D.)
    K925816 SHARPS CONTAINMENT SYSTEM
    K830947 SYRINGE/NEEDLE DISPOS-BOX-CUTTER/CRIMPER