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510(k) K120123

AQUASHIELD CO2 SYSTEM by United States Endoscopy Group, Inc. — Product Code FEQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2012
Date Received
January 17, 2012
Clearance Type
Traditional
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)
  • K172805 — gi-4000 Electrosurgical Generator (October 23, 2017)
  • K163495 — AdvanCE capsule endoscope delivery device (March 10, 2017)
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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)