BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

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

    K Number: K973364 · Decision Mar 17, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    9
    Review Days
    190

    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
    4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
    K Number
    K973364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maersk Medical A/S
    Date Received
    September 8, 1997
    Decision Date
    March 17, 1998
    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

    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

    LIBERTY VALVE

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

    Other Clearances by Maersk Medical A/S

    K Number Device Name
    K011071 PARADIGM QUICK-SET INFUSION SET
    K002138 PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
    K990112 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
    K990110 DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
    K990111 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
    K990115 DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
    K990113 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
    K991759 MAERSK MEDICAL CONTOUR INFUSION SET