BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam

    Reg #: 3016544248 · FEI: 3016544248 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    ANX ROBOTICA CORP.
    Registration Number
    3016544248
    FEI Number
    3016544248
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6010 W. Spring Creek Pkwy
    City
    Plano
    State
    TX
    ZIP
    75024
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221608

    Owner / Operator

    Firm Name
    AnX Robotica Corp.
    Operator Number
    10062363
    Address
    6010 W. Spring Creek Pkwy
    City
    Plano
    State
    TX
    Postal Code
    75024
    Country
    US
    Correspondent
    Tim Thomas

    Products

    Device Name Product Code
    Magnetically Maneuvered Capsule Endoscopy System QKZ

    Proprietary Names

    NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether NaviCam Tether

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198