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510(k) K233321

Double Balloon Endoscope EN-840T, Over-tube TS-1214C by Fujifilm Healthcare Americas Corporation — Product Code FDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2024
Date Received
September 29, 2023
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 Healthcare Americas Corporation

  • K251204 — FUJIFILM Stiffening Wire Device (SW-2000) (September 26, 2025)
  • K243647 — Synapse PACS (7.5) (June 30, 2025)
  • K233629 — APERTO Lucent MRI System (May 10, 2024)
  • K233687 — ECHELON Synergy V10.0 (May 3, 2024)
  • K233583 — FCT iSTREAM Phase 1 (April 26, 2024)
  • K240075 — FUJIFILM Endoscope Model EB-710XT (February 7, 2024)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231941 — ARIETTA x10 (November 20, 2023)
  • K231574 — Scenaria View 4.2 (October 12, 2023)
  • K230752 — Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) (September 15, 2023)

Other clearances for product code FDA

  • K251204 — FUJIFILM Stiffening Wire Device (SW-2000) (September 26, 2025)
  • 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)
  • K060923 — NAVIAID BGE DEVICE, MODEL 21-001 (August 15, 2006)