LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070374
    Device Name
    ARTHROCARE ENT PLASMA WAND
    Manufacturer
    ARTHROCARE CORP.
    Date Cleared
    2007-04-25

    (76 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K014290,K063538
    Predicate For
    K083415,K100543,K100597,K122652,K123353,K142999,K172647,K192027,K202006
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ArthroCare ENT Plasma Wands is for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

    • Adenoidectomy
    • Cysts
    • Head, Neck, Oral, and Sinus Surgery
    • Mastoidectomy
    • Myringotomy with Effective Hemorrhage Control
    • Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
    • Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
    • Neck Mass
    • Papilloma Keloids
    • Submucosal Palatal Shrinkage
    • Submucosal Tissue Shrinkage
    • Tonsillectomy (including palatine tonsils)
    • Traditional Uvulopalatoplasty (RAUP)
    • Tumors
    • Tissue in the Uvula/Soft Palate for the Treatment of Snoring
    Device Description

    The ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in otorhinolaryngology (ENT) surgery.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the ArthroCare ENT® Plasma Wands™. The document is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices and listing the intended uses of the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1