Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Flexible video colonoscope, reusable FDA UDI
Device Name: This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes. FDA UDI
Model / Reference: EC-760S-A/L FDA UDI
Description: This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410425178 FDA UDI
510(k) Number: K223827 FDA UDI
FDA Product Code: QTH FDA UDI
FDF FDA UDI
GMDN Term: Flexible video colonoscope, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1530 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

Yes

FDA UDI

Category: Flexible video colonoscope, reusable

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

Similar devices

Also classified as Flexible video colonoscope, reusable.

PENTAX — HOYA CORPORATION · Class II
VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
Endoch — Endoch Inc · Class II
VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
PENTAX — HOYA CORPORATION · Class II
EVIS EXERA lll COLONOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II

Cleared under the same submission

K223827 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 d55f621f-0b3c-4844-b295-a228a8243535 36 fields · synced May 30, 2026