Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Flexible ultrasound gastroduodenoscope FDA UDI
Device Name: FUJIFILM Endoscope Model EG-580UT is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs of the esophagus, stomach, and duodenum. FDA UDI
Model / Reference: EG-580UT FDA UDI
Description: FUJIFILM Endoscope Model EG-580UT is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs of the esophagus, stomach, and duodenum. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410349061 FDA UDI
510(k) Number: K221952 FDA UDI
FDA Product Code: ITX FDA UDI
ODG FDA UDI
FDS FDA UDI
GMDN Term: Flexible ultrasound gastroduodenoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
876.1500 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

FDA UDI

Category: Flexible ultrasound gastroduodenoscope

Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Flexible ultrasound gastroduodenoscope.

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Cleared under the same submission

K221952 also covers:

FUJIFILM — FUJIFILM 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: FUJIFILM Corporation

Sources (1)

FDA UDI f2793f02-4057-40e5-81d1-742397d44d7f 36 fields · synced Jun 8, 2026