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

    Omnifix Syringe NRFit

    K Number: K241385 · Decision Jul 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    4
    Applicant Total
    149
    Review Days
    59

    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
    Omnifix Syringe NRFit
    K Number
    K241385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.Braun Medical, Inc.
    Date Received
    May 15, 2024
    Decision Date
    July 13, 2024
    Product Code
    QEH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

    Similar 510(k) Clearances

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

    Artiglass NRFitTM Tip L.O.R. Glass Syringes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NRFit® Caps, Male and Female Neuraxial Tip Caps

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Syringe NRFit Lok and BD Syringe NRFit Slip

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NRFit Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by B.Braun Medical, Inc.

    K Number Device Name
    K253235 Introcan Safety® Deep Access XL IV Catheter
    K243392 Infusomat® Space Volumetric Infusion Pump Administration Sets
    K240578 VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
    K241845 Introcan Safety® 2 IV Catheter
    K231242 Perifix FX Catheter; Contiplex FX Catheter
    K223479 AQUAbase nX
    K220756 Introcan Safety 2 IV Catheter
    K220626 Introcan Safety IV Catheter
    K213778 IV Administration Set
    K213664 B. Braun Introcan Safety 2 IV Catheter
    Search all 149 clearances from B.Braun Medical, Inc. →