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510(k) Data Aggregation

    K Number
    K233500
    Device Name
    Benesta Tissue Removal Device
    Manufacturer
    Caldera Medical, Inc.
    Date Cleared
    2023-11-30

    (30 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Special
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Benesta Tissue Removal Device

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

    The Caldera Medical BenestaTM Tissue Removal Device is intrauterine use by trained surgeons to hysteroscopically resect and remove tissue, such as: submucous myomas, endometrial polyps, and retained products of conception.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Benesta™ Tissue Removal Device), which confirms substantial equivalence to a predicate device. However, it does not include details about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies. Therefore, I cannot generate the table or answer the specific questions regarding the device's technical validation.

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