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

    Ancora Nerve Block Catheter Set

    K Number: K191290 · Decision Feb 6, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    1
    Review Days
    269

    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
    Ancora Nerve Block Catheter Set
    K Number
    K191290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ancora Medical Technology
    Date Received
    May 13, 2019
    Decision Date
    February 6, 2020
    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