Skip to content

Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530H)

by Fujifilm Medical System U.S.A., Inc.

510(k) K122535

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 NumberK122535 Date13 Dec 2012ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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/Fujifilm EB-530 Series Bronchoscopes are electronic bronchoscopes intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree. They incorporate reliable endoscopic technologies to provide high-quality images and improve operability in bronchial care.

These devices are supplied as reusable endoscopic instruments and are authorized under FDA 510(k) clearance K122535. They are manufactured by Fujifilm Medical System U.S.A., Inc. and are classified under product code EOQ with advisory committee review in ENT (Ear, Nose, Throat).

Other devices from Fujifilm Medical System U.S.A., Inc.

See all devices from Fujifilm Medical System U.S.A., Inc. →

Questions

AI-generated answers, 25 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 is the Fujinon EB-530 Series Bronchoscope used for?

    The Fujinon EB-530 Series Bronchoscope is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree, providing high-quality images and improved operability in bronchial care through reliable endoscopic technologies.

  • Is the Fujinon EB-530 Series Bronchoscope reusable or single-use?

    The Fujinon EB-530 Series Bronchoscopes are supplied as reusable endoscopic instruments, meaning they are designed for multiple uses after proper cleaning and reprocessing in accordance with manufacturer guidelines.

  • What regulatory authorization does the Fujinon EB-530 Series Bronchoscope have?

    The device is authorized under FDA 510(k) clearance K122535, indicating it was found substantially equivalent to a legally marketed predicate device through a traditional review process.

  • What models are included in the Fujinon EB-530 Series Bronchoscope family?

    The Fujinon EB-530 Series includes three models: EB-530S, EB-530T, and EB-530H, all manufactured by Fujifilm Medical System U.S.A., Inc. and classified under product code EOQ with ENT advisory committee review.