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510(k) K143556

Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T by Fujifilm Medical Systems U.S.A, Inc. — Product Code FDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2015
Date Received
December 15, 2014
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 Fujifilm Medical Systems U.S.A, Inc.

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  • K173132 — ASPIRE Cristalle (October 27, 2017)
  • K171463 — ASPIRE Bellus II (September 29, 2017)
  • K152257 — Fujifilm Duodenoscope Model ED-530XT (July 21, 2017)
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  • K171096 — Fujifilm Diathermic Slitter (FlushKnife) (May 9, 2017)
  • K170858 — FDR AQRO (DR-XD 1000) (April 24, 2017)
  • K162287 — Synapse 3D Perfusion Analysis (April 6, 2017)

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  • 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)
  • K071254 — SMALL INTESTINAL VIDEOSCOPE SYSTEM (March 25, 2008)
  • K060923 — NAVIAID BGE DEVICE, MODEL 21-001 (August 15, 2006)