BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Asensus Surgical, Inc.

    Reg #: 3007593944 · FEI: 3007593944 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    Asensus Surgical, Inc.
    Registration Number
    3007593944
    FEI Number
    3007593944
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1001 Airport Blvd, Suite 110
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182421

    Owner / Operator

    Firm Name
    Asensus Surgical, Inc
    Operator Number
    10029161
    Address
    1001 Airport Blvd, Suite 110
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Casey Hinckley

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Camera, Television, Endoscopic, With Audio FWG
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Senhance Ultrasonic System Senhance X9007741 Senhance Connect Senhance Surgical System

    Establishment Types

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