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

    GETTIG UNIVERSAL VIAL ACCESS PIN

    K Number: K041232 · Decision Jul 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    73

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    Basic Information

    Device Name
    GETTIG UNIVERSAL VIAL ACCESS PIN
    K Number
    K041232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gettig Pharmaceutical Instrument Co.
    Date Received
    May 10, 2004
    Decision Date
    July 22, 2004
    Product Code
    LHI
    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
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Gettig Pharmaceutical Instrument Co.

    K Number Device Name
    K033409 AMERSHAM HEALTH NEEDLE-GUARD
    K022495 GETTIG DISPOSABLE SYRINGES
    K000455 GETTIG GUARD
    K972285 GETTIG STYRL-JECT DELIVERY SYSTEM