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510(k) Data Aggregation

    K Number
    K252874
    Device Name
    Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
    Manufacturer
    Serpex Medical, Inc.
    Date Cleared
    2025-10-08

    (28 days)

    Product Code
    KTI
    Regulation Number
    874.4680
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K221206
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Compass Steerable Needle is a steerable transbronchial biopsy needle intended to be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.

    Device Description

    The Compass Steerable Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions. The Compass Steerable Needle include two model numbers, Model CSN1001 and Model CSN1002. Model CSN1001 includes two accessory adapters for attachment to bronchoscopes.

    The subject of this 510(k) is the addition of two new adapters to Model CSN1002. Adapter SRA-1-01 connects the Model CSN1002 to the Ion™ Endoluminal System, and Adapter SRA-2-01 connects the Model CSN1002 to the Monarch™ Platform or Galaxy System™.

    AI/ML Overview

    N/A

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