BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ClearScope

    Reg #: 3016804805 · FEI: 3016804805 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    CLEARCAM
    Registration Number
    3016804805
    FEI Number
    3016804805
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8000 Centre Park Dr, 170
    City
    Austin
    State
    TX
    ZIP
    78754
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200228

    Owner / Operator

    Firm Name
    ClearCam
    Operator Number
    10072510
    Address
    8000 Centre Park Drive, 170
    City
    Austin
    State
    TX
    Postal Code
    78754
    Country
    US
    Correspondent
    Chris Idelson

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    ClearScope ClearCam Kelling System ClearCam System Kelling

    Establishment Types

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