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510(k) Data Aggregation

    K Number
    DEN230078
    Device Name
    Versius Surgical System
    Date Cleared
    2024-10-11

    (325 days)

    Product Code
    Regulation Number
    878.4964
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    Product Code :

    SCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Versius Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing. The Versius Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.
    Device Description
    The Versius Surgical System is intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures. The system comprises (Figure 1): - . a surgeon console, - a visualization bedside unit . - . up to three instrument bedside units - . surgical attachments comprising an endoscopic camera and surgical instruments, - . and sterile drapes Each bedside unit includes a robot arm to which the endoscopic camera and instruments are attached.
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