BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Heel Incision Safety Lancet

    K Number: K210745 · Decision Aug 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    9
    Review Days
    167

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    Basic Information

    Device Name
    Heel Incision Safety Lancet
    K Number
    K210745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SteriLance Medical (Suzhou), Inc.
    Date Received
    March 12, 2021
    Decision Date
    August 26, 2021
    Product Code
    FMK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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    Other Clearances by SteriLance Medical (Suzhou), Inc.

    K Number Device Name
    K261634 Disposable Blood Lancet (Soft)
    K244036 Heel Incision Safety Lancet (SteriHeel 2)
    K244031 Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
    K233796 Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
    K221521 Disposable Safety Lancet
    K221507 Disposable Blood Lancet
    K221970 Lancing device
    K153706 Insulin Pen Needle