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

    URO-TOTE LEG BAG

    K Number: K921024 · Decision Sep 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    6
    Review Days
    183

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    Basic Information

    Device Name
    URO-TOTE LEG BAG
    K Number
    K921024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neotech Products, Inc.
    Date Received
    March 3, 1992
    Decision Date
    September 2, 1992
    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

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    Other Clearances by Neotech Products, Inc.

    K Number Device Name
    K011564 NEOLEAD
    K931727 URINARY DRAINAGE BAG CADDY
    K890425 NEOTECH MUCUS TRAP W/CATHETER
    K882203 NEOTECH UNIVERSAL ADAPTER
    K880487 NEOTECH MECONIUM ASPIRATOR (STERILE)