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510(k) K162622

Fujifilm Endoscope Models EC-600HL and EC-600LS by Fujifilm Medical Systems U.S.A, Inc. — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2016
Date Received
September 20, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

To examine or perform procedures in the colon or rectum 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.

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  • 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)
  • K162749 — FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (June 15, 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)

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  • K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL) (January 3, 2025)
  • K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (October 4, 2024)
  • K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, (February 16, 2024)
  • K231254 — GripTract-GI Endoscopic Tissue Manipulator (November 3, 2023)
  • K232922 — Pure-Vu EVS System (October 20, 2023)
  • K230332 — Ambu® aScope™ Colon; Ambu® aBox™ 2 (September 15, 2023)