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510(k) K160275

Fuse Endoscopic System with FuseBox Processor by Endochoice, Inc. — Product Code PEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2016
Date Received
February 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Accessories, Image Post-Processing For Color Enhancement
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.

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  • K153588 — EndoChoice Water Bottle Cap System (February 24, 2016)
  • K151475 — EndoChoice Select Injection Needle (February 8, 2016)
  • K152182 — Fuse Gastroscopy System (December 10, 2015)
  • 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)

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