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510(k) Data Aggregation

    K Number
    K223520
    Device Name
    UNIDRIVE SIII System
    Manufacturer
    Karl Storz-Endoscopy-America, Inc.
    Date Cleared
    2023-04-27

    (155 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Karl Storz-Endoscopy-America, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIDRIVE SIII System is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue. The HOPKINS Telescope when used with the obturator is intended to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
    Device Description
    The UNIDRIVE® SIII system is a motorized surgical device intended for intrauterine use to hysteroscopically resect and remove tissue. The UNIDRIVE SIII System includes the following components: UNIDRIVE SIII Control Unit (20701020-1) Footswitch (20016230) DrillCut-X II Shaver handpiece GYN (26702050) Shaver blades (26208SA, 26208SB) HOPKINS Telescope (26208AMA) Obturator (26208OC) The UNIDRIVE S III system has a motor control unit and can be used with the DrillCut-X II Shaver handpiece GYN which houses the shaver blades. The shaver blade upon being connected to the DrillCut-X II Shaver handpiece GYN is inserted into the working channel of the HOPKINS Telescopes. The shaver blades are activated via a one-pedal footswitch that is connected the UNIDRIVE SIII control unit. The shaver blades consist of two sheaths that fit into each other. The inner sheath oscillates within the outer sheath to enable tissue resection.
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    K Number
    K201399
    Device Name
    HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
    Manufacturer
    Karl Storz-Endoscopy-America, Inc.
    Date Cleared
    2020-08-17

    (81 days)

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

    Karl Storz-Endoscopy-America, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG 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. Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. The KARL STORZ VITOM II ICG System is intended for capturing fluorescent mages for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.
    Device Description
    The modified KARL STORZ ICG Imaging System includes the following components: i) Modified 10mm and 5mm HOPKINS ICG/NIR Rigid Endoscopes (0°, 30°, 45°): have an improved optical design with the white light and NIR images in good focus simultaneously. ii) Power LED Rubina Light Source and Footswitch: The light source has two LEDs, white light and NIR. iii) Image1 S 4U Rubina Camera Head: uses a 2 chip 4K camera head that houses 2 CMOS sensors: one for white light and the other for NIR. iv) Camera Control Unit: Image1 S Connect II (TC201US) and Image1 S 4U- Link (TC304US): is used with the Image1 S 4U Rubina Camera Head to output a 4K image to the monitor.
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