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

    FLEXISCOPE, MODELS 50MH AND 50 MHC

    K Number: K053412 · Decision Feb 23, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    78

    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
    FLEXISCOPE, MODELS 50MH AND 50 MHC
    K Number
    K053412
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schoelly Imaging, Inc.
    Date Received
    December 7, 2005
    Decision Date
    February 23, 2006
    Product Code
    FWF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FWF Camera, Television, Endoscopic, Without Audio

    Similar 510(k) Clearances

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

    KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VES 1501-M

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ANGIOLAZ VES-1CAM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Schoelly Imaging, Inc.

    K Number Device Name
    K090800 VS-100 ILLUMINATION AND IMAGING SYSTEM
    K090601 FSC 2
    K083553 NASO-LARYNGO-PHARYNGOSCOPE
    K060899 FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE