Home / 510(k) Clearances / K162749

510(k) K162749

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR by Fujifilm Medical Systems U.S.A, Inc. — Product Code FDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2017
Date Received
September 30, 2016
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 Systems U.S.A, Inc.

  • K171291 — FUJIFILM Bronchoscope Model EB-530P (January 19, 2018)
  • K171207 — FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (January 11, 2018)
  • K173132 — ASPIRE Cristalle (October 27, 2017)
  • K171463 — ASPIRE Bellus II (September 29, 2017)
  • K152257 — Fujifilm Duodenoscope Model ED-530XT (July 21, 2017)
  • K163624 — Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL (June 30, 2017)
  • 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)
  • K170451 — FDX Console (DR-ID300CL) Software (March 16, 2017)

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)