BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3.2-PED-EGD-F EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Gastroscope Fuji

    Reg #: 3011697028 · FEI: 3011697028 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    DEN200016

    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 Pancreatic Debridement Device QNE

    Proprietary Names

    3.2-PED-EGD-F EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Gastroscope Fuji PED-PURGE EndoRotor® Purge Kit 6-PED-EGD EndoRotor® 6mm Powered Endoscopic Debridement (PED) Catheter ESS-CONSOLE EndoRotor® EndoSurgery System - Console 3.2-PED-EGD-OP EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Gastroscope Olympus/Pentax 3.2-PED-COL-OP EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Colonoscope Long Olympus/Pentax

    Establishment Types

    Manufacture Medical Device