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510(k) Data Aggregation

    K Number
    K251227
    Device Name
    da Vinci Surgical System (IS5000)
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2025-09-08

    (140 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K143132,K232610
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K143132

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

    It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

    Contraindication:
    Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

    Device Description

    The da Vinci Surgical System, Model IS5000, is a software-controlled, electro-mechanical system designed to enable complex surgery using a minimally invasive approach. The system consists of a Console (Surgeon Console or SSC), a Robot (Patient Side Cart orPSC), and a Tower (Vision Side Cart or VSC) and is used with an endoscope, instruments, and accessories.

    The basis for this submission is the initial submission of the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software is being modified to include compatibility support of Harmonic ACE™ Curved Shears. Harmonic ACE™ Curved Shears was previously cleared to be used with da Vinci Surgical Systems Model IS4000 under K143132. This modification does not change the Harmonic ACE™ Curved Shears. It changed the da Vinci Surgical System Model IS5000 software to allow Harmonic ACE™ Curved Shears to be used with the IS5000 system. This modification also includes changes to the da Vinci Surgical System, Model IS5000 device labeling for instruments and accessories.

    AI/ML Overview

    N/A

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