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510(k) Data Aggregation

    K Number
    K221778
    Device Name
    Disposable Safety Lancets
    Manufacturer
    Suzhou Kyuan Medical Apparatus Co., Ltd.
    Date Cleared
    2022-10-03

    (104 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Kyuan Medical Apparatus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature.
    Device Description
    The Disposable Safety Lancets consists 7 parts, include a lancet cap, body, slide, lancet, tip cover, spring and bottom. The models of the Disposable Safety Lancets are 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G. The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature. The lancet is hit by pressure, and once the device strikes, the lancet needle can puncture the skin. Used Gamma sterilization, and are products for single use.
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    K Number
    K220387
    Device Name
    Disposable Blood Lancets
    Manufacturer
    Suzhou Kyuan Medical Apparatus Co., Ltd.
    Date Cleared
    2022-08-17

    (188 days)

    Product Code
    QRL, QRK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Kyuan Medical Apparatus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The lancet is intended to be assembled with a lancing device, such that once the lancing device is launched, the needle of the lancet can prick the skin.
    Device Description
    The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G. Disposable Blood Lancets are used to collect blood samples for hospital clinic test. It is sterilized by Irradiation and is a single-use product.
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