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510(k) K163424

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

K163424 is an FDA 510(k) premarket notification submitted by United State Endoscopy Group, Inc. for the device "AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON". The FDA issued a decision of Substantially Equivalent on January 4, 2017. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2017
Date Received
December 6, 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

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)
  • 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)

FDA data resources