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510(k) Data Aggregation

    K Number
    K221042
    Device Name
    Renova RP Centesis Pump
    Manufacturer
    GI Supply, Inc.
    Date Cleared
    2023-04-19

    (376 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    GI Supply, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The Renova RP Centesis Pump is intended to be used by trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
    Device Description
    The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP® Tube Set and RenovaRP® Fluid Drainage Bags (provided separately from the pump) to remove fluid from the abdominal cavity for paracentesis, and pleural effusion from the thoracic cavity for thoracentesis.
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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?
    Applicant Name (Manufacturer) :

    Gi Supply, Inc

    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?
    Applicant Name (Manufacturer) :

    GI Supply

    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
    K031360
    Device Name
    GI SUPPLY BILIARY STENT
    Manufacturer
    GI SUPPLY
    Date Cleared
    2003-09-24

    (147 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    GI SUPPLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GI Supply Biliary Stent is a disposable single-use device intended for use to temporarily by-pass obstructions in the biliary tree and allow drainage into the duodenum.
    Device Description
    The GI Supply Biliary Stent is a disposable single-use device.
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    K Number
    K012411
    Device Name
    HP-ONE
    Manufacturer
    GI SUPPLY
    Date Cleared
    2001-09-25

    (57 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    GI SUPPLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HP-ONE is for in-vitro diagnostic use only. It is intended to detect the urease enzyme of Helicobacter pylori and provide a presumptive diagnosis of H. pylori gastritis.
    Device Description
    HP-ONE detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. A gastric mucosal endoscopic biopsy is placed in the HP-ONE tray well and a reagent containing urea, hydrogen peroxide, a pH dye indicator, and an acidic buffer is placed over the biopsy specimen. A bubbling reaction occurs as catalase breaks down the peroxide. If H. pylori is present, the urease in H. pylori converts the urea to ammonia which raises the pH and changes the color of the reagent, indicating a positive test.
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    K Number
    K970186
    Device Name
    GI SUPPLY PARACENTESIS PUMP
    Manufacturer
    GI SUPPLY
    Date Cleared
    1997-02-14

    (28 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    GI SUPPLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970187
    Device Name
    RUNYON LARGE VOLUME PARACENTESIS KIT
    Manufacturer
    GI SUPPLY
    Date Cleared
    1997-02-14

    (28 days)

    Product Code
    LRO
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    GI SUPPLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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