Home / 510(k) Clearances / K191559

510(k) K191559

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM by United States Endoscopy Group, Inc. — Product Code FEQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2019
Date Received
June 13, 2019
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 United States Endoscopy Group, Inc.

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  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K192059 — Bio Guard Air/Water & Suction Valves (September 17, 2019)
  • K182909 — Roth Net Retriever Product Line (November 21, 2018)
  • 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)
  • K163492 — Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex (January 6, 2017)
  • K153362 — AquaShield system CO2, AquaShield system-PENTAX (December 16, 2015)

Other clearances for product code FEQ

  • K220395 — EndoGator Endoscopy Irrigation Tubing (March 11, 2022)
  • 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)
  • K133747 — ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM (January 8, 2014)