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

    AMSINO URINARY LEG BAG

    K Number: K971929 · Decision Aug 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    9
    Review Days
    71

    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
    AMSINO URINARY LEG BAG
    K Number
    K971929
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amsino Intl., Inc.
    Date Received
    May 27, 1997
    Decision Date
    August 6, 1997
    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

    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 Amsino Intl., Inc.

    K Number Device Name
    K070873 AMSURE BLADDER IRRIGATION SET
    K992719 AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
    K974042 AMSURE CLEANSING ENEMA SET
    K973107 AMSINO I.V. ADMINISTRATION SET
    K973199 AMSINO SUCTION CATHETER
    K964745 AMSINO URINARY DRAINAGE BAG
    K950780 AMSINO CERVICAL SCRAPER
    K951528 AMSINO DISPOSABLE VIGINAL SPECULUM