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510(k) K133747

ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM by Endochoice, Inc. — Product Code FEQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2014
Date Received
December 9, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Air, Non-Manual, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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)
  • 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)

Other clearances for product code FEQ

  • K220395 — EndoGator Endoscopy Irrigation Tubing (March 11, 2022)
  • K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIF (August 1, 2019)
  • K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - (September 21, 2018)
  • K173650 — AquaShield System CO2- Fujifilm (January 5, 2018)
  • K163424 — AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO (January 4, 2017)
  • K162152 — Erbe’s CO2 Tubing/Cap Sets (August 31, 2016)
  • K161482 — EndoChoice Water Bottle Cap Irrigation System (June 27, 2016)
  • K153588 — EndoChoice Water Bottle Cap System (February 24, 2016)
  • K153362 — AquaShield system CO2, AquaShield system-PENTAX (December 16, 2015)
  • K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM (January 20, 2015)