PENTAX Medical

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name: PENTAX Medical FDA UDI
Generic Name: Flexible ultrasound gastroduodenoscope FDA UDI
Device Name: PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT (Made in Malaysia) FDA UDI
Model / Reference: EG38-J10UT FDA UDI
Description: PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT (Made in Malaysia) FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333249015 FDA UDI
510(k) Number: K200090 FDA UDI
FDA Product Code: ODG FDA UDI
ITX FDA UDI
GMDN Term: Flexible ultrasound gastroduodenoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible ultrasound gastroduodenoscope

PENTAX Medical by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible ultrasound gastroduodenoscope.

EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
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EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
ULTRASONIC GASTROVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
ULTRASOUND GASTROSCOPE — PENTAX of America, Inc. · Class II
FUJIFILM — FUJIFILM Corporation · Class II
ULTRASOUND GASTROSCOPE — PENTAX of America, Inc. · Class II
FUJIFILM — FUJIFILM Corporation · Class II

Cleared under the same submission

K200090 also covers:

PENTAX Medical — HOYA CORPORATION
PENTAX Medical — HOYA CORPORATION

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Hoya Corporation

Sources (1)

FDA UDI c03fe25d-6015-427d-9f61-d7ef182182e8 34 fields · synced Jun 6, 2026