BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (GLOBAL)

    Reg #: 2936485 · FEI: 2936485 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    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
    K201361

    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
    Insufflator, Endoscopic Vessel Harvesting OSV
    Insufflator, Laparoscopic HIF

    Proprietary Names

    PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (GLOBAL) PNEUMOCLEAR CO2 CONDITIONING INSUFFLATOR (North America) PNEUMOCLEAR HIGH-FLOW TUBE SET PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (North America) PNEUMOCLEAR HEATED HIGH-FLOW TUBE SET PNEUMOCLEAR HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET PNEUMOCLEAR HEATED HUMIDIFIED TUBE SET PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET PNEUMOCLEAR CO2 CONDITIONING INSUFFLATOR (GLOBAL)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility