BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AIM HD LAPAROSCOPE, AUTOCLAVABLE, 5.4MM x 30, 30CM

    Reg #: 2936485 · FEI: 2936485 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    4

    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
    K210088

    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
    Light, Catheter, Fiberoptic, Glass, Ureteral FCS

    Proprietary Names

    AIM HD LAPAROSCOPE, AUTOCLAVABLE, 5.4MM x 30, 30CM AIM 4K Coupler, 20mm, C-Mount AIM HD LAPAROSCOPE, AUTOCLAVABLE, 10MM x 30, 33CM L11 LED Light Source with AIM 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER 1688 Camera Control Unit SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY, 5 MM SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY, RIGHT ANGLE, 5 MM 1688 AIM 4K CAMERA HEAD, C-MOUNT AIM SAFELIGHT™ FIBER OPTIC CABLE, 5MM X 10FT / 35M AIM HD LAPAROSCOPE, AUTOCLAVABLE, 5.4MM x 0, 30CM 1688 Pendulum Camera Head with Coupler AIM HD LAPAROSCOPE, AUTOCLAVABLE, 10MM x 0, 33CM 1688 AIM 4K INLINE CAMERA HEAD, C-MOUNT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device