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

    URINARY DRAINAGE BAG

    K Number: K935557 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    24
    Review Days
    110

    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
    URINARY DRAINAGE BAG
    K Number
    K935557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Puritas Health Care, Inc.
    Date Received
    November 17, 1993
    Decision Date
    March 7, 1994
    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 Puritas Health Care, Inc.

    K Number Device Name
    K942339 SKIN NEUVEAU SCAR TREATMENT
    K941197 SILK*SKIN SCAR TREATMENT
    K935600 TRACHEAL SUCTION CATHETER
    K935531 OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
    K940074 Y-TYPE BLOOD ADMINISTRATION SET
    K940055 MULTISET
    K940054 MEASURED VOLUME SOLUTION ADMINISTRATION SET
    K935583 SUCTION SET, TRACHAEL
    K940056 WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM
    K935532 TRANSFER SET
    Search all 24 clearances from Puritas Health Care, Inc. →