LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972749
    Device Name
    PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
    Manufacturer
    C.M. CHANCE LTD.
    Date Cleared
    1998-03-13

    (233 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)

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

    The Pao Bipolar Coaxial Coagulator is for cauterizing microscopic vessels on the conjunctiva and sclera. It is for extraocular surgery and it is not to be used for intraocular surgery (within the anterior or posterior segment of the eye).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "PAO BIPOLAR COAXIAL COAGULATOR." It indicates that the device has been found substantially equivalent to a predicate device. However, this type of document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications as it is a regulatory clearance, not a study report.

    Therefore, I cannot provide the requested information from the provided text. The document only states that the device is cleared for marketing based on substantial equivalence.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1