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

    PROSYS LEG BAG

    K Number: K952208 · Decision Aug 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    81
    Review Days
    97

    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
    PROSYS LEG BAG
    K Number
    K952208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec, A Division of E.R. Squibb & Sons
    Date Received
    May 10, 1995
    Decision Date
    August 15, 1995
    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 Convatec, A Division of E.R. Squibb & Sons

    K Number Device Name
    K013814 ABSORBENT ANTIMICROBIAL WOUND DRESSING
    K990964 SIGNADRESS DUODERM DRESSING
    K984388 HA ABSORBENT WOUND DRESSING
    K980720 NONWOVEN PAD
    K980382 NON-WOVEN COMPRESS
    K974823 NONWOVEN DRESSING
    K974205 KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
    K974304 GERMICIDAL CLOTH
    K973632 DUODERM CGF CONTROL GEL FORMULA DRESSING
    K972530 CONVATEC ODOR CONTROL WOUND DRESSING
    Search all 81 clearances from Convatec, A Division of E.R. Squibb & Sons →