BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Athena Surgical RMUS System

    Reg #: 3018783201 · FEI: 3018783201 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ATHENA SURGICAL
    Registration Number
    3018783201
    FEI Number
    3018783201
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6110 Blue Circle Drive, Suite 280
    City
    Minnetonka
    State
    MN
    ZIP
    55343
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210087

    Owner / Operator

    Firm Name
    Athena Surgical
    Operator Number
    10081489
    Address
    6110 Blue Circle Drive, Suite 280
    City
    Minnetonka
    State
    MN
    Postal Code
    55343
    Country
    US
    Correspondent
    Greg Slusser

    Products

    Device Name Product Code
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN

    Proprietary Names

    Athena Surgical RMUS System

    Establishment Types

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