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510(k) K091773

FUJINON STERILE OVERTUBES by Fujinon, Inc. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2009
Date Received
June 16, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

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)
  • 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)
  • K050907 — FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P (May 19, 2005)
  • 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)

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