BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Fluorescence Assessment Software

    Reg #: 2936485 · FEI: 2936485 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    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
    K202244

    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
    Confocal Optical Imaging OWN
    System, X-Ray, Angiographic IZI

    Proprietary Names

    SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Fluorescence Assessment Software SPY-PHY Handheld Imager SPY Portable Handheld Imaging (SPY-PHI) System with SPY-PHI Fluorescence Assessment Software Pinpoint Light Cable Video Processor / Illuminator VPI

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198