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510(k) Data Aggregation

    K Number
    K980536
    Device Name
    EPIDURAL NEEDLE
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-07-31

    (170 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K030562,K032981
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the epidural placement, directly or through a catheter, of anesthetic agents to elicit regional anesthesia.

    Device Description

    Epidural Needle (Touhy, Hustead, Crawford, Weiss)

    AI/ML Overview

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

    However, this document does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to the request.

    Therefore, I cannot provide the requested table and study details based on the provided text. The document is solely a regulatory clearance letter.

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