BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    ENVISION ENDOSCOPY INC.

    · Expires 2026
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ENVISION ENDOSCOPY INC.
    Status
    Inactive
    Expiry Year
    2026
    Initial Importer
    No
    Address
    204 Second Ave
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242923

    Owner / Operator

    Firm Name
    ENVISION ENDOSCOPY INC.
    Operator Number
    10095994
    Address
    204 Second Ave
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US
    Correspondent
    Azadeh Khanicheh

    Products

    Device Name Product Code
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Endoscopic Tissue Approximation Device OCW

    Proprietary Names

    SimpleSnip Suture Cutter SimpleStitch Suturing System

    Establishment Types

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