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510(k) K050907

FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P by Fujinon, Inc. — Product Code EOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2005
Date Received
April 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bronchoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

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 reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Fujinon, Inc.

  • K120446 — FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 (August 13, 2012)
  • K112391 — FUJINON COLONOSCOPES (July 26, 2012)
  • K102466 — FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR (May 25, 2011)
  • K111243 — FUJINON ULTRASONIC PROCESSOR (May 16, 2011)
  • K091773 — FUJINON STERILE OVERTUBES (August 7, 2009)
  • K090116 — FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 (April 22, 2009)
  • K063316 — FUJINON MODEL EG-530N TRANS NASAL INSERTION (March 16, 2007)
  • K063847 — FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 (March 1, 2007)
  • K042043 — FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 (November 24, 2004)
  • K042076 — FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 (November 18, 2004)

Other clearances for product code EOQ

  • K250863 — FUJIFILM Ultrasonic Endoscope EB-710US (December 12, 2025)
  • K251731 — KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (December 5, 2025)
  • K252045 — Ion Endoluminal System (IF1000) (September 23, 2025)
  • K251894 — Himaging Bronchscope System (September 23, 2025)
  • K252528 — Ion Endoluminal System (IF1000) (September 5, 2025)
  • K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (August 27, 2025)
  • K251823 — UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchosco (August 11, 2025)
  • K250232 — Vathin® Video Bronchoscope System (July 25, 2025)
  • K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEO (June 23, 2025)
  • K244017 — FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (June 13, 2025)