FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

FDA 510(k) K253137 · Fujifilm Corporation

Substantially Equivalent

510(k) numberK253137

Submission

Device name
FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
Applicant
Fujifilm Corporation
Ashigara Kami-Gun, JP
Received
September 25, 2025
Decision date
June 16, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EOQ – Bronchoscope (Flexible Or Rigid)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4680
Specialty
Ear, Nose, Throat

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…

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Questions and answers

When was FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T cleared by the FDA?

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T (K253137) received a 510(k) decision of Substantially Equivalent on June 16, 2026, 264 days after the submission was received.

What is the product code of K253137?

The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.