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510(k) Data Aggregation

    K Number
    K983620
    Device Name
    MANAN SPINAL NEEDLES
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1999-01-08

    (85 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MANAN SPINAL NEEDLES

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

    For the spinal administration of anesthetic agents to elicit regional anesthesia.

    Device Description

    Spinal Needle

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a spinal needle. It does not contain any information about acceptance criteria, device performance studies, or the use of AI/algorithms.

    Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study designs. The document is strictly a regulatory clearance letter acknowledging substantial equivalence to a predicate device.

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