BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Senhance Surgical System

    Reg #: 3007593944 · FEI: 3007593944 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Asensus Surgical, Inc.
    Registration Number
    3007593944
    FEI Number
    3007593944
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1 TW Alexander Drive, Suite 160
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171120

    Owner / Operator

    Firm Name
    Asensus Surgical, Inc
    Operator Number
    10029161
    Address
    1 TW Alexander Drive, Suite 160
    City
    Durham
    State
    NC
    Postal Code
    27703
    Country
    US
    Correspondent
    Casey Hinckley

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    Senhance Surgical System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device