BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS

    K Number: K143159 · Decision Jan 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    34
    Applicant Total
    6
    Review Days
    81

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS
    K Number
    K143159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spineguard S.A.
    Date Received
    November 3, 2014
    Decision Date
    January 23, 2015
    Product Code
    PDQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PDQ Neurosurgical Nerve Locator

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PDQ), ordered by most recent decision date.

    Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Neuralytix iD3 System (NTX-9001)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TELIGEN System Peripheral Motor Nerve Stimulation Indications

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ATEC IOM Accessory Instruments

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PediGuard Threaded

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Neurosign V4 Intraoperative Nerve Monitor

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Spineguard S.A.

    K Number Device Name
    K220160 PediGuard Threaded
    K201454 DSG Connect Technology
    K162884 SpineGuard DSG Zavation Screw System
    K152747 DSG Threaded Drill System
    K123390 PEDIGUARD NERVE DETECTOR SYSTEM