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Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270P

by Fujinon, Inc.

510(k) K050907

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050907 Date19 May 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EOQ
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fujinon G5 Bronchoscopes are flexible bronchoscopic instruments designed to provide visual access to the tracheobronchial tree for diagnostic and therapeutic procedures. They enable clinicians to inspect, sample, and treat airway lesions through a slender, maneuverable shaft equipped with an optical system.

The devices are offered in three model variants—EB-470S, EB-250S, and EB-270P—and have been cleared by the U.S. FDA through a 510(k) submission (K050907) as substantially equivalent to a predicate device. They are classified as Class II medical devices (product code EOQ) and are subject to the associated special controls.

Other devices from Fujinon, Inc.

See all devices from Fujinon, Inc. →

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical procedures can the Fujinon G5 bronchoscopes be used for?

    They are designed for both diagnostic and therapeutic airway procedures, allowing clinicians to visually inspect the tracheobronchial tree, obtain tissue samples, and deliver treatment to lesions because the shaft is flexible and equipped with an optical system.

  • Are the G5 bronchoscopes supplied as single-use or reusable devices?

    The device description does not specify single‑use status, so they are assumed to be reusable instruments that must be reprocessed according to the manufacturer’s instructions and applicable sterilization standards.

  • What are the differences between the EB-470S, EB-250S, and EB-270P models?

    All three share the same G5 platform, but they differ in shaft length and tip configuration, which affect reach and maneuverability within the airway. Selecting a model depends on the specific anatomical region and procedural requirements.

  • How is the Fujinon G5 bronchoscope regulated in the United States?

    It was cleared by the FDA through a traditional 510(k) submission (K050907) as substantially equivalent to a predicate device, placing it in Class II under product code EOQ and subject to the associated special controls.