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

    SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)

    K Number: K133316 · Decision May 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    14
    Review Days
    212

    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
    SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
    K Number
    K133316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epimed International, Inc.
    Date Received
    October 28, 2013
    Decision Date
    May 28, 2014
    Product Code
    BSO
    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
    BSO Catheter, Conduction, Anesthetic

    Similar 510(k) Clearances

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

    EDEN ControlCath

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Perifix FX Catheter; Contiplex FX Catheter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SubQKath Catheter and Needle Set

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Percutaneous Introducer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    C-CAT Anaesthesia Catheter kit

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

    Other Clearances by Epimed International, Inc.

    K Number Device Name
    K200624 Percutaneous Introducer
    K190256 Rulo Radiofrequency Lesion Probe
    K053318 RX EPIDURAL NEEDLE
    K051171 STINGRAY EPIDURAL CATHETER CONNECTOR
    K051860 FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
    K043467 FLEXIBLE SPINAL NEEDLE
    K041021 RF INTRODUCTION CANNULA
    K041843 PENCIL POINT NEEDLE
    K023140 VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
    K030562 TUOHY EPIDURAL NEEDLE
    Search all 14 clearances from Epimed International, Inc. →