BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇸🇬 Singapore

    APA Oxy Blade

    K Number: K191602 · Decision Aug 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    63
    Applicant Total
    6
    Review Days
    46

    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
    APA Oxy Blade
    K Number
    K191602
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5540
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Venner Medical (Singapore) Pte, Ltd.
    Date Received
    June 17, 2019
    Decision Date
    August 2, 2019
    Product Code
    CCW
    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
    CCW Laryngoscope, Rigid

    Similar 510(k) Clearances

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

    Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    YEESCOPE LARYNGOSCOPES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    AIRTRAQ SP AIRTRAQ AVANT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    TRU-MR LARYNGOSCOPE SET

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by Venner Medical (Singapore) Pte, Ltd.

    K Number Device Name
    K192511 Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
    K192120 Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm
    K110631 VENNER TRACHEAL SEAL MONITOR
    K100950 VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
    K093135 VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE