BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTEGRATED ENDOSCOPY, INC.

    Reg #: 3011401113 · FEI: 3011401113 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    19
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    INTEGRATED ENDOSCOPY, INC.
    Registration Number
    3011401113
    FEI Number
    3011401113
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    16 Technology Drive, Suite 165
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191594

    Owner / Operator

    Firm Name
    Integrated Endoscopy, Inc.
    Operator Number
    10048466
    Address
    16 Technology Drive, Suite 165
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Albert Rego

    Products

    Device Name Product Code
    Arthroscope HRX
    Accessories, Arthroscopic NBH
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Nuvis Battery Arthroscope IE4030ATX-10 IE4030-10 IE4030SNN-10 IE4030SNN IE4030ATX IE4030 Nuvis Obturator Nuvis Trocar Nuvis Cannula Nuvis Cannula System IE20CMT IE58CAN-1 IE58CAN-2 IE18CMT IE58OB IE58TR Nuvis® Wireless HD Camera System (Nuvis-2K) nuVIS

    Establishment Types

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