BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Precision S 4K Sinuscopes, 4mm x 70, 155mm, Reverse Cant

    Reg #: 2936485 · FEI: 2936485 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    30
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    STRYKER ENDOSCOPY
    Registration Number
    2936485
    FEI Number
    2936485
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5900 Optical Ct
    City
    SAN JOSE
    State
    CA
    ZIP
    95138
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211202

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ
    Light Source, Fiberoptic, Routine FCW
    Confocal Optical Imaging OWN
    Endoscope, Neurological GWG
    Light, Catheter, Fiberoptic, Glass, Ureteral FCS

    Proprietary Names

    Precision S 4K Sinuscopes, 4mm x 70, 155mm, Reverse Cant Precision S 4K Sinuscopes, 3.1mm x 45, 170mm, Reverse Cant Precision S 4K Sinuscopes, 3.1mm x 0, 125mm AIM 4K Coupler, 20mm, C-Mount Precision S 4K Sinuscopes, 4mm x 0, 180mm Precision S 4K Sinuscopes, 4mm x 45, 155mm Precision S 4K Sinuscopes, 3.1mm x 30, 170mm 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER 1688 Pendulum Camera Head with Coupler Precision S 4K Sinuscopes, 4mm x 30, 155mm Precision S 4K Sinuscopes, 3.1mm x 70, 125mm SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY, RIGHT ANGLE, 5 MM Precision S 4K Sinuscopes, 4mm x 70, 180mm AIM SAFELIGHT FIBER OPTIC CABLE, 5MM X 10FT / 35M Precision S 4K Sinuscopes, 4mm x 45, 155mm, Reverse Cant 1688 AIM 4K INLINE CAMERA HEAD, C-MOUNT Precision S 4K Sinuscopes, 3.1mm x 30, 125mm L11 LED Light Source with AIM Precision S 4K Sinuscopes, 4mm x 30, 155mm, Reverse Cant Precision S 4K Sinuscopes, 3.1mm x 70, 170mm Precision S 4K Sinuscopes, 3.1mm x 30, 170mm, Reverse Cant Precision S 4K Sinuscopes, 3.1mm x 0, 170mm Precision S 4K Sinuscopes, 3.1mm x 45, 170mm Precision S 4K Sinuscopes, 4mm x 30, 180mm, Reverse Cant Precision S 4K Sinuscopes, 4mm x 0, 155mm Precision S 4K Sinuscopes, 4mm x 70, 155mm SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY, 5 MM Precision S 4K Sinuscopes, 3.1mm x 70, 170mm, Reverse Cant 1688 AIM 4K CAMERA HEAD, C-MOUNT 1688 Camera Control Unit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device