BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3.2-EPR-COL-O EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short Olympus

    Reg #: 3011697028 · FEI: 3011697028 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INTERSCOPE, INC.
    Registration Number
    3011697028
    FEI Number
    3011697028
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Commerce Dr.
    City
    Northbridge
    State
    MA
    ZIP
    01534
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181127

    Owner / Operator

    Firm Name
    INTERSCOPE., INC
    Operator Number
    10054826
    Address
    200 Commerce Dr
    City
    Northbridge
    State
    MA
    Postal Code
    01534
    Country
    US
    Correspondent
    JEFFERY RYAN

    Products

    Device Name Product Code
    Endoscopic Morcellator Gastroenterology PTE

    Proprietary Names

    3.2-EPR-COL-O EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short Olympus 6-EPR-EGD EndoRotor® 6mm Endoscopic Powered Resection (EPR) Catheter ESS-CONSOLE EndoRotor® EndoSurgery System - Console 3.2-EPR-COL-OP EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long Olympus/Pentax EPR-TRAP EndoRotor® Specimen Trap 3.2-EPR-EGD-F EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Fuji 3.2-EPR-EGD-OP EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Olympus/Pentax CATHGUIDE EndoRotor® Catheter Guide

    Establishment Types

    Manufacture Medical Device