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

    ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300

    K Number: K972878 · Decision Oct 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    10
    Review Days
    87

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    Basic Information

    Device Name
    ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
    K Number
    K972878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Safety Syringes, Inc.
    Date Received
    August 4, 1997
    Decision Date
    October 30, 1997
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMF Syringe, Piston

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    Other Clearances by Safety Syringes, Inc.

    K Number Device Name
    K123743 ULTRASAFE PLUS PASSIVE NEEDLE GUARD
    K122558 ULTRASAFE PASSIVE NEEDLE GUARD
    K060743 MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)
    K042712 TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
    K013801 ULTRASAFE DENTAL INJECTION SYSTEM
    K011369 ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
    K972877 ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD
    K972900 ULTRASAFE MODEL T200 INJECTOR
    K944425 ULTRASAFE ASPIRATING SYRINGE