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510(k) K183032

FUJIFILM Double Balloon Endoscope EI580BT by Fujifilm Corporation — Product Code FDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2019
Date Received
November 1, 2018
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).

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Other clearances for product code FDA

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  • 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)
  • 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)
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