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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?
    Product Code :

    PLL

    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?
    Product Code :

    PLL

    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.
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    K Number
    K221385
    Device Name
    LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
    Manufacturer
    Ovesco Endoscopy AG
    Date Cleared
    2022-08-11

    (90 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    PLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gel is an injection agent for endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD).
    Device Description
    Not Found
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    K Number
    K200071
    Device Name
    Blue Beacon Submucosal Injectable Solution
    Manufacturer
    Micro-Tech (Nanjing) Co., Ltd.
    Date Cleared
    2020-11-03

    (295 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    PLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early state cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
    Device Description
    Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. Under the surveillance of endoscope, in conjunction with endoscopic injection needles with a diameter equal to or greater than 23G are recommended), inject the product beneath the lesion until enough submucosal lift. It is supplied in a 5 mL, 10ml syringe. The contents of the syringe are sterile and nonpyrogenic. The proposed devices are moist heat sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 2 years.
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    K Number
    K202376
    Device Name
    EverLift Submucosal Lifting Agent
    Manufacturer
    Gi Supply, Inc.
    Date Cleared
    2020-09-30

    (41 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    PLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.
    Device Description
    The GI Supply EverLift™ Submucosal Lifting Agent (10mL) is a prefilled plastic syringe with attached plunger rod containing 10mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available endoscopic injection needle. EverLift™ Submucosal Lifting Agent is an injectable liguid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD), and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers, and other pathological lesions by EMR, ESD, or polypectomy. EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD, or polypectomy).
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    K Number
    K191923
    Device Name
    EverLift Submucosal Lifting Agent
    Manufacturer
    GI Supply
    Date Cleared
    2020-06-20

    (338 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    PLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.
    Device Description
    The GI Supply EverLift™ Submucosal Lifting Agent is a prefilled plastic syringe with attached plunger rod containing 5mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available, endoscopic injection needle. The EverLift™ Submucosal Lifting Agent is an injectable liquid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy. EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal laver, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).
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    K Number
    K191254
    Device Name
    EndoClot
    Manufacturer
    EndoClot Plus Co., Ltd.
    Date Cleared
    2020-01-30

    (265 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    PLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EndoClot® Submucosal Injection Agent is intended 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
    EndoClot® Submucosal Injection Agent is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a plastic bottle and a spiral plunger syringe. AMP® particles are dissolved with sterile 0.9% saline to make the agent prior to use. The syringe has a Luer lock fitting to ensure a secure connection to a standard, commercially available endoscopic injection needle. The agent can be injected by rotating the plunger.
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    K Number
    K180068
    Device Name
    ORISE Gel
    Manufacturer
    Boston Scientific
    Date Cleared
    2018-09-28

    (262 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    PLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device 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 other suitable endoscopic device.
    Device Description
    The ORISE™ Gel device is a viscous dyed solution which is pre-filled into a standard luer lock syringe for use in submucosal injection to lift gastrointestinal mucosa during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, such as the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy. The Injection is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope.
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    K Number
    K150852
    Device Name
    SIC 8000
    Manufacturer
    COSMO TECHNOLOGIES, LTD.
    Date Cleared
    2015-09-03

    (156 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    PLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIC 8000 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 other suitable endoscopic device.
    Device Description
    SIC 8000 is an injectable liquid composition in the form of an oil-in-water (o/w) emulsion for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, such as the esophagus, the small intestine, the colon, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy. SIC 8000 is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The emulsion, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).
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