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510(k) Data Aggregation

    K Number
    K951928
    Device Name
    DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
    Manufacturer
    CSEN LTD.
    Date Cleared
    1997-05-30

    (766 days)

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

    DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)

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

    Not Found

    Device Description

    Double-Holed Pencil Point Spinal Needle (DHPP)

    AI/ML Overview

    This is an FDA premarket notification (510(k)) letter for a medical device. This type of document is a clearance letter, not a study report or a detailed description of device performance or clinical trials. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document.

    This letter only states that the device, a "Double-Holed Pencil Point Spinal Needle (DHPP)," has been found "substantially equivalent" to legally marketed predicate devices. It does not contain details about specific acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

    To answer your questions, one would need access to the 510(k) submission document itself, which would include the performance data and the comparison to the predicate device.

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