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510(k) K120446

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 by Fujinon, Inc. — Product Code FDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2012
Date Received
February 14, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Fujinon, Inc.

  • 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)
  • K042076 — FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 (November 18, 2004)

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)