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510(k) Data Aggregation

    K Number
    K061201
    Date Cleared
    2006-05-30

    (29 days)

    Product Code
    Regulation Number
    876.1075
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087

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

    The dSnare Diminutive Polypectomy and Suction System is a non-diathermic device with a suction retrieval feature indicated for transendoscopic polypectomy and suction retrieval of lesions between 3mm and 7mm in size.

    Device Description

    The dSnare Diminutive Polypectomy and Suction System is a non-diathermic device with a suction retrieval feature.

    AI/ML Overview

    This document is a marketing authorization letter (510(k) clearance) from the FDA for a medical device called the "dSnare™ Diminutive Polypectomy and Suction System."

    Crucially, this document does not contain any information regarding acceptance criteria, study details, or device performance metrics. It merely states that the device has been found substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is strictly a regulatory clearance and does not include the technical details of device validation.

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