BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ActivSight Intraoperative Imaging System

    Reg #: 3021336392 · FEI: 3021336392 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Activ Surgical Inc
    Registration Number
    3021336392
    FEI Number
    3021336392
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    27-43 Wormwood St Ste 400
    City
    Boston
    State
    MA
    ZIP
    02210
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203550

    Owner / Operator

    Firm Name
    ActivSurgical
    Operator Number
    10083945
    Address
    27-43 Wormwood Street, Suite 400
    City
    Boston
    State
    MA
    Postal Code
    02210
    Country
    US
    Correspondent
    Peter Ohanian

    Products

    Device Name Product Code
    Confocal Optical Imaging OWN

    Proprietary Names

    ActivSight Intraoperative Imaging System

    Establishment Types

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