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

    FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837

    K Number: K051860 · Decision Aug 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    9
    Applicant Total
    14
    Review Days
    45

    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
    FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
    K Number
    K051860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epimed International, Inc.
    Date Received
    July 8, 2005
    Decision Date
    August 22, 2005
    Product Code
    MIA
    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
    MIA Needle, Spinal, Short Term

    Similar 510(k) Clearances

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

    Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REGANES SPINAL NEEDLE (VARIOUS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEO-CARE LUMBER PUNCTURE KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES

    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
    K133316 SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
    K053318 RX EPIDURAL NEEDLE
    K051171 STINGRAY EPIDURAL CATHETER CONNECTOR
    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. →