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510(k) K993704

GASTRO-INTESTINAL SYSTEM EN-410WM by Fujinon, Inc. — Product Code FDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2000
Date Received
November 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteroscope And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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)
  • 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)

Other clearances for product code FDA

  • K251204 — FUJIFILM Stiffening Wire Device (SW-2000) (September 26, 2025)
  • K233321 — Double Balloon Endoscope EN-840T, Over-tube TS-1214C (June 13, 2024)
  • K231323 — Ancora-SB (August 31, 2023)
  • K223295 — Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (January 11, 2023)
  • K213195 — Balloon BS-3 (October 29, 2021)
  • K191330 — Arc Enterocuff (January 31, 2020)
  • K183032 — FUJIFILM Double Balloon Endoscope EI580BT (June 24, 2019)
  • K183683 — FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 (February 27, 2019)
  • K143556 — Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (August 20, 2015)
  • K071254 — SMALL INTESTINAL VIDEOSCOPE SYSTEM (March 25, 2008)