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510(k) Data Aggregation

    K Number
    K241591
    Device Name
    Blue Eye
    Manufacturer
    The Standard Co., Ltd.
    Date Cleared
    2024-07-03

    (30 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    The Standard Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blue Eye is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device.
    Device Description
    Blue Eye, submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointestinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.
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    K Number
    K220434
    Device Name
    Blue Eye (TS-905)
    Manufacturer
    The Standard Co., Ltd.
    Date Cleared
    2022-08-12

    (178 days)

    Product Code
    PLL, 21C
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    The Standard Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blue Eye (TS-905) is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions with a snare or endoscopic device.
    Device Description
    The Blue Eye (TS-905), submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointenstinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.
    Ask a Question

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