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510(k) K152182

Fuse Gastroscopy System by Endochoice, Inc. — Product Code FDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2015
Date Received
August 5, 2015
Clearance Type
Special
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 Endochoice, Inc.

  • K160275 — Fuse Endoscopic System with FuseBox Processor (August 1, 2016)
  • K161482 — EndoChoice Water Bottle Cap Irrigation System (June 27, 2016)
  • K161167 — Seal Single-Use Biopsy Valve (May 26, 2016)
  • K160403 — SmartStart Air/Water and Suction Valves (May 19, 2016)
  • K153588 — EndoChoice Water Bottle Cap System (February 24, 2016)
  • K151475 — EndoChoice Select Injection Needle (February 8, 2016)
  • K152580 — rescuenet (November 3, 2015)
  • K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM (January 20, 2015)
  • K140472 — BONASTENT TRACHEAL / BRONCHIAL (October 17, 2014)
  • K141598 — FUSE COLONOSCOPY SYSTEM (September 30, 2014)

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)