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510(k) Data Aggregation

    K Number
    K252010
    Device Name
    SPY Laparoscope
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    2025-07-24

    (27 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250820
    Device Name
    Disposable Trocars
    Manufacturer
    Sinolinks Medical Innovation, Inc.
    Date Cleared
    2025-07-11

    (115 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243399
    Device Name
    Boehringer Laboratories Liver Retractor
    Manufacturer
    Boehringer Laboratories, LLC
    Date Cleared
    2025-07-02

    (244 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251490
    Device Name
    8 mm Assist Cannula; 12 mm Assist Cannula
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2025-07-02

    (49 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251209
    Device Name
    Medical Monitor (32HS710S)
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2025-06-12

    (55 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.
    Device Description
    32HS710S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as Display port, HDMI, DVI and SDI. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 100% of the sRGB spectrum.
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    K Number
    K250728
    Device Name
    Arthrex Synergy Vision Endoscopic Imaging System
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2025-05-05

    (55 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. The Arthrex Synergy Vision Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The Arthrex NanoNeedle Scope when used with the Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.
    Device Description
    The Arthrex Synergy Vision Endoscopic Imaging System includes a camera control unit (CCU) console, camera heads, endoscopes, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging. The Arthrex Synergy Vision Endoscopic Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the laparoscope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.
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    K Number
    K243867
    Device Name
    LAGIS Suction Irrigation System
    Manufacturer
    Lagis Enterprise Co., Ltd.
    Date Cleared
    2025-03-17

    (90 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
    Device Description
    The LAGIS Suction Irrigation System consists of flexible tubing attached to a plastic housing/handle with a spring activated valve/stopper. Attached distally is a stainless steel probe and proximally is a plastic housing cap. When properly connected and operated, the device irrigates and evacuates fluids during laparoscopic procedures. The LAGIS Suction Irrigation System has multiple models, which can be categorized into two types based on the handle design, including direct type (e.g., SA-360C) and trumpet type (e.g., SA-320CT). Despite the different handle designs, all models provide the same function.
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    K Number
    K250411
    Device Name
    DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
    Manufacturer
    Dannik, LLC
    Date Cleared
    2025-03-12

    (27 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.
    Device Description
    The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment of the bag with the use of the biasing arms.
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    K Number
    K243439
    Device Name
    Medical Monitor (27HS714S)
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2025-01-28

    (83 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.
    Device Description
    27HS714S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as Display port, HDM, DVI and SDI. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 99% of the sRGB spectrum.
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    K Number
    K243008
    Device Name
    Arthrex NanoScope System
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2025-01-22

    (118 days)

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

    GCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arthrex NanoScope System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, and urology. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoScope System is indicated for use in laparoscopy and orthopedic procedures.
    Device Description
    The Arthrex NanoScope System provides real-time visible light illumination and imaging. The system includes a non-sterile reusable camera control unit (CCU) console and sterile disposable camera handpieces. The system integrates high-definition camera technology, LED lighting, and an imaging management system into a single console with touchscreen interface.
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