Home / 510(k) Clearances / K160275

510(k) K160275

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

K160275 is an FDA 510(k) premarket notification submitted by Endochoice, Inc. for the device "Fuse Endoscopic System with FuseBox Processor". The FDA issued a decision of Substantially Equivalent on August 1, 2016. The device falls under product code PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement), a Class II device regulated under 21 CFR 876.1500. Endochoice, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Endochoice, Inc.

  • 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)
  • 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)

Other clearances for product code PEA

  • K251127 — PENTAX Medical Video Processor (EPK-i8020c) (June 3, 2025)
  • K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope E (July 28, 2023)
  • K190805 — PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope E (December 20, 2019)
  • K191282 — PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (November 8, 2019)
  • K173679 — PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (July 3, 2018)
  • K150618 — PENTAX Medical EPK-i7010 Video Processor with GI Family (November 24, 2015)
  • K140149 — EPX-4440HD DIGITAL VIDEO PROCESSOR (August 22, 2014)
  • K122470 — PENTAX EPK-I5010 VIDEO PROCESSOR (April 10, 2013)

FDA data resources