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510(k) K041903

FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 by Fujinon, Inc. — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2004
Date Received
July 14, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colonoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine or perform procedures in the colon or rectum 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)

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  • K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal (May 15, 2025)
  • K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL) (January 3, 2025)
  • K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (October 4, 2024)
  • K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, (February 16, 2024)
  • K231254 — GripTract-GI Endoscopic Tissue Manipulator (November 3, 2023)
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