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510(k) K153206

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 by Fujifilm Medical System U.S.A., Inc. — Product Code FDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2016
Date Received
November 5, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

To examine or perform procedures in the stomach. 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 System U.S.A., Inc.

  • K163675 — Processor VP-7000, Light Source BL-7000 (April 25, 2017)
  • K151474 — Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (February 18, 2016)
  • K152138 — FDR D-EVO GL Flat Panel Detector System (November 5, 2015)
  • K150221 — EPX-4440HD and EPX-4400HD with FICE (October 1, 2015)
  • K142629 — EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (May 14, 2015)
  • K142003 — FDR D-EVO II FLAT PANEL DETECTOR SYSTEM (October 21, 2014)
  • K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATOR (September 9, 2014)
  • K132188 — MAMMOGRAPHY VIEWER SMV658 (October 25, 2013)
  • K130542 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (June 14, 2013)
  • K130383 — SYNAPSE 3D CARDIAC TOOLS (April 9, 2013)

Other clearances for product code FDS

  • K250550 — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (February 17, 2026)
  • K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; (February 6, 2026)
  • K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Vid (December 16, 2025)
  • K251041 — GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (October 31, 2025)
  • K251708 — EvoEndo Single-Use Endoscopy System (October 10, 2025)
  • K243388 — Disposable Distal Cap (June 27, 2025)
  • K250900 — EvoEndo Single-Use Endoscopy System (June 16, 2025)
  • K243512 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM End (June 10, 2025)
  • K242635 — Endoscopic Distal Attachment (AF-D series) (May 30, 2025)
  • K250296 — Disposable Distal Attachment D-201 Series (May 1, 2025)