BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Endoplus Hand-held Laparoscopic Instruments

    Reg #: 1423714 · FEI: 3000719482 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    ENDOPLUS
    Registration Number
    1423714
    FEI Number
    3000719482
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    750 Tower Rd Ste A
    City
    Mundelein
    State
    IL
    ZIP
    60060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151567

    Owner / Operator

    Firm Name
    ENDOPLUS
    Operator Number
    9005786
    Address
    750 Tower Road, SUITE A
    City
    Mundelein
    State
    IL
    Postal Code
    60060
    Country
    US
    Correspondent
    Matthew S Gudeman

    Products

    Device Name Product Code
    Coagulator, Culdoscopic (And Accessories) HFI

    Proprietary Names

    Endoplus Hand-held Laparoscopic Instruments

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Remanufacture Medical Device Manufacture Medical Device