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

    ACUFEX T-FIX DELIVERY SYSTEM

    K Number: K942442 · Decision Dec 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    9
    Applicant Total
    78
    Review Days
    196

    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
    ACUFEX T-FIX DELIVERY SYSTEM
    K Number
    K942442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acufex Microsurgical, Inc.
    Date Received
    May 23, 1994
    Decision Date
    December 5, 1994
    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

    FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837

    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
    View all

    Other Clearances by Acufex Microsurgical, Inc.

    K Number Device Name
    K961555 ACUFEX TAG BIOABSORBABLE ANCHORS
    K961853 PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
    K954246 ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
    K952535 ACUFEX ENDOBUTTON TAPE
    K953276 ACUFEX TAG DELIVERY SYSTEM
    K953459 ACUFEX TAG ANCHOR
    K941740 ACUFEX ROTATOR CUFF FIXATION BUTTON
    K944500 ACUFEX PATELLAR BONE BLOCK SIZER
    K951859 ACUFEX ENDOBUTTON PACK
    K946346 ACUFEX TAG(R) BIOABSORBABLE ANCHORS
    Search all 78 clearances from Acufex Microsurgical, Inc. →