BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mount 2B SOLOASSIST II

    Reg #: 2936485 · FEI: 2936485 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    1

    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
    K171947

    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
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    Mount 2B SOLOASSIST II Mount 1B SOLOASSIST II Mount 2A SOLOASSIST II Power Cord C7 SOLOASSIST II Tension Sleeve D5mm SOLOASSIST II Joystick LH SOLOASSIST II Mount 1A SOLOASSIST II Supply Cable SOLOASSIST II Trolley SOLOASSIST II Retrofit Set Small Parts Tray SOLOASSIST II Sterilization Tray with small parts tray SOLOASSIST II Joystick LH and Drape Pack SOLOASSIST II Tension Sleeve D12.7mm SOLOASSIST II Box Sterile Drape 10 SOLOASSIST II Adaptor 2 SOLOASSIST II SOLOASSIST II Kit SOLOASSIST II Cone Adapter SOLOASSIST II Adaptor 1 SOLOASSIST II Universal Joint SOLOASSIST II SOLOASSIST II SOLOASSIST II Joystick RH SOLOASSIST II Sterile Drape, Single Use, SOLOASSIST II Tension Sleeve D10mm SOLOASSIST II Sterile Set with small parts tray SOLOASSIST II Tension Sleeve D4mm SOLOASSIST II Joystick RH and Drape Pack SOLOASSIST II Endoscope Clamp SOLOASSIST II Power Supply SOLOASSIT II

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198