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510(k) Data Aggregation

    K Number
    K241360
    Device Name
    Universal Seal (5-12 mm)
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2024-08-05

    (83 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K152448,K113706,K231358
    Why did this record match?
    Reference Devices :

    K152448,K113706

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

    The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

    Device Description

    The Universal Seal (5-12 mm) is a sterile, single-use device. It provides a seal within a port of entry for endoscopes, instruments, and accessories with a diameter range between 5 mm and 12 mm. It also provides an attachment for insufflation accessories and allows for air to flow in or out of the body cavity while minimizing gas leakage.

    AI/ML Overview

    I am sorry. This document does not contain information about acceptance criteria and device performance for an AI/ML device. It describes a medical device, the Universal Seal (5-12 mm), which is a physical seal used in endoscopic procedures. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to a predicate device, specifically highlighting a minor material change and biocompatibility testing. It does not involve any AI or machine learning components.

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