BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TFL-FBX550S

    Reg #: 3011050570 · FEI: 3011050570 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Gyrus ACMI, Inc.
    Registration Number
    3011050570
    FEI Number
    3011050570
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9600 Louisiana Ave North
    City
    Brooklyn Park
    State
    MN
    ZIP
    55445
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242191

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    TFL-FBX550S TFL-FBX940S TFL-FBX550R TFL-FBX150R TFL-FBX200S TFL-FBX150S TFL-PLS TFL-FBX200R TFL-CSLU TFL-FBX365S Powered laser surgical instrument (TFL-AFSWL) TFL-FBX200BS TFL-CPLU TFL-FBX365R TFL-FBX940R TFL-SLS TFL-FBX150BS

    Establishment Types

    Manufacture Medical Device