BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type)

    Reg #: 9610877 · FEI: 3008185830 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HOYA Corporation PENTAX Lifecare Division
    Registration Number
    9610877
    FEI Number
    3008185830
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Tsutsujigaoka 1-1-110
    City
    Akishima-shi Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K200090

    Owner / Operator

    Firm Name
    HOYA Corporation PENTAX Division
    Operator Number
    8030235
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    Postal Code
    07645
    Country
    US
    Correspondent
    Gurvinder Nanda

    US Agent

    Business Name
    HOYA CORPORATION PENTAX DIVISION
    Contact Name
    Gurvinder Nanda
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    ZIP
    07645
    Country
    US
    Email
    [email protected]
    Phone
    201 5712318

    Products

    Device Name Product Code
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type) PENTAX Medical EG-J10U Endoscopic Ultrasound System (EUS-J10) EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type) EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) PENTAX Medical Cleaning Adapter(OE-G1) PENTAX Medical Suction/Balloon Suction Control Valve(OF-B206) CLEANING ADAPTER FOR EG34-J10U (OE-B10) Round Trip Carrying Case (VE-G25) PENTAX Medical Air/Water/balloon Feeding Valve(OF-B207) PENTAX Medical O-Ring Set For EUS-J10 (OF-B219) SINGLE USE BALLOON (OE-A60)

    Establishment Types

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