BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Veloxion Controller Kit (PN 2516)

    Reg #: 3028977843 · FEI: 3028977843 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    AULEA MEDICAL, INC.
    Registration Number
    3028977843
    FEI Number
    3028977843
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5627 Stoneridge Dr Ste 312
    City
    Pleasanton
    State
    CA
    ZIP
    94588
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230205

    Owner / Operator

    Firm Name
    Aulea Medical, Inc.
    Operator Number
    10088655
    Address
    5627 Stoneridge Dr., Suite 312
    City
    Pleasanton
    State
    CA
    Postal Code
    94588
    Country
    US
    Correspondent
    George Hsu

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Evacuator, Gastro-Urology KQT
    Resectoscope FJL

    Proprietary Names

    Veloxion Controller Kit (PN 2516) Veloxion Resectoscope (PN 2490) Waste Management Tubing (PN 1878) Veloxion Fluid Control Set (PN 1327) Veloxion Roll Stand (PN 2517) Tissue Catch (PN 1877)

    Establishment Types

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