BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE

    K Number: K030618 · Decision May 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    125
    Review Days
    90

    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
    WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
    K Number
    K030618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    February 26, 2003
    Decision Date
    May 27, 2003
    Product Code
    BSP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

    Similar 510(k) Clearances

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

    SonoMSK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SonoPlex STIM; SonoPlex II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SonoTAP and SonoTAP II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SonoBlock; SonoBlock II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Wilson-Cook Medical, Inc.

    K Number Device Name
    K253302 Hemospray Endoscopic Hemostat (HEMO-[X])
    K243568 Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
    K213356 Entuit PEG, Entuit PEGJ
    K212323 Instinct Plus Endoscopic Clipping Device
    K201322 Entuit Nasal Jejunal Feeding Tube
    K200972 Hemospray Endoscopic Hemostat
    K200247 Fusion Quattro Extraction Balloon
    K192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
    K193344 Tri-Ex Extraction Balloon with Multiple Sizing
    K192908 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
    Search all 125 clearances from Wilson-Cook Medical, Inc. →