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510(k) Data Aggregation

    K Number
    K253978

    Validate with FDA (Live)

    Device Name
    Universal Seal (5-12 mm)
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2026-02-24

    (74 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K241360
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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

    N/A

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