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510(k) Data Aggregation

    K Number
    K093043
    Device Name
    ZIRCONIA SYRINGE NEEDLE
    Manufacturer
    KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD
    Date Cleared
    2010-08-20

    (324 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ZIRCONIA SYRINGE NEEDLE

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

    The Zirconia syringe needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Zirconia Syringe Needle." It states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, this document does not contain information about acceptance criteria or studies proving device performance for an AI/ML powered device.

    The provided text is a regulatory clearance for a traditional medical device (a syringe needle), not an AI/ML-powered one. The questions in the prompt are specifically designed to elicit information about the development and validation of AI/ML models. Since this document does not pertain to such a device, the requested information cannot be extracted.

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