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

    ASSURE-MALE EXTERNAL INCONTINCE CATHETER

    K Number: K821848 · Decision Aug 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    10
    Review Days
    49

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ASSURE-MALE EXTERNAL INCONTINCE CATHETER
    K Number
    K821848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Design & Manufacturing Corp.
    Date Received
    June 22, 1982
    Decision Date
    August 10, 1982
    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

    Similar 510(k) Clearances

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

    IBAG

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BESECURE EXTERNAL URINARY COLLECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMSINO URINARY LEG BAG

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WELCON HUE-VU URINARY DRAINAGE BAG

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Medical Design & Manufacturing Corp.

    K Number Device Name
    K911911 MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM
    K914384 MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE
    K911366 PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE
    K902822 MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE
    K895604 SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES
    K880492 INTERCEPT T.E.N.S. DEVICE
    K834138 HYPO SUTURE
    K811224 MINISTIM
    K810222 LIMB ORHTOSIS