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510(k) Data Aggregation

    K Number
    K970069
    Device Name
    DUAL HOOK FIBEROPTIC DELIVERY SYSTEM
    Manufacturer
    IHD, INC.
    Date Cleared
    1998-07-17

    (555 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dual Hook Scalpel, fiberoptic delivery system is indicated for use in cutting, and coagulation of soft tissues encountered in general surgical applications. This includes incision, excision, or coagulation of tissue.

    Device Description

    Dual Hook Scalpel (fiberoptic delivery system)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Dual Hook Scalpel (Fiber Optic Delivery System)". This document is a regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that are typically found in a clinical study report. Therefore, I cannot extract the requested information from this document.

    The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

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