LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974313
    Device Name
    HYDROFERA SURGICAL SPEAR
    Manufacturer
    HYDROFERA, LLC.
    Date Cleared
    1998-03-02

    (105 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYDROFERA SURGICAL SPEAR

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

    Hydrofera TM ophthalmic sponges are intended as external wicking device for use in local management of fluids during cataract surgery.

    Device Description

    Ophthalmic Sponge

    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 an ophthalmic sponge and outlines regulatory information, but it does not detail any acceptance criteria, study methodologies, performance metrics, or ground truth establishment for a device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1