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510(k) K162152

Erbe’s CO2 Tubing/Cap Sets by Erbe USA, Inc. — Product Code FEQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2016
Date Received
August 2, 2016
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

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  • 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)
  • 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)
  • K133747 — ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM (January 8, 2014)