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510(k) Data Aggregation

    K Number
    K252442
    Device Name
    Kii Structural Balloon Access System
    Manufacturer
    Applied Medical Resources Corp.
    Date Cleared
    2025-10-31

    (88 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K060096,K182024,K942636
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K060096, K182024

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

    Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.

    Device Description

    Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.

    The system is composed of four main components:

    • An obturator that facilitates insertion of the system through an incision.
    • A cannula with bolster and attached balloon, encased within a perforated sheath.
    • A seal which maintains insufflation.
    • An inflation bulb that is used to manually inflate and deflate the balloon.
    AI/ML Overview

    N/A

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