BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE

    K Number: K971377 · Decision Apr 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    63
    Applicant Total
    9
    Review Days
    381

    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
    GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
    K Number
    K971377
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5540
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson Greatbatch Technologies, Inc.
    Date Received
    April 14, 1997
    Decision Date
    April 30, 1998
    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.

    APA Oxy Blade

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    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
    View all

    Other Clearances by Wilson Greatbatch Technologies, Inc.

    K Number Device Name
    K971374 GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
    K972280 GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K971781 GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
    K970619 GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
    K971375 GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
    K954649 WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP
    K950063 WGL ENDOSCOPIC GRASPER*
    K942168 WGL ENDOSCOPIC GRASPER