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510(k) Data Aggregation

    K Number
    K012003
    Device Name
    DRG REACTION CHAMBER/SAFETY TIP
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2002-02-12

    (230 days)

    Product Code
    HEI,GEI
    Regulation Number
    884.2660
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K001936
    Why did this record match?
    Product Code :

    HEI

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

    The DRG Reaction Chamber/Safety Tip is indicated for use as an accessory to standard ablation electrosurgical wands which do not have irrigation and vacuum extraction attached to them. The device provides continuous irrigation and vacuum extraction at the ablation site.

    Device Description

    The DRG Reaction Chamber/Safety Tip is an accessory for Coblation® electrosurgical devices. It creates a sealed chamber during ablation, ensuring continuous liquid supply and suction.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the DRG Reaction Chamber/Safety Tip, primarily focusing on its substantial equivalence to a predicate device for market clearance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies.

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