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

    HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO

    K Number: K011925 · Decision Jul 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    12
    Review Days
    22

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    Basic Information

    Device Name
    HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
    K Number
    K011925
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sims Portex, Inc.
    Date Received
    June 20, 2001
    Decision Date
    July 12, 2001
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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