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FDA 510(k)

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON

K-Number: K163424 · 2017-01-04

ApplicantUnited State Endoscopy Group, Inc.
Decision Date2017-01-04
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is a medical device manufactured by United State Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2017-01-04 under approval number K163424. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON?

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is a medical device that received FDA 510(k) clearance on 2017-01-04. It is manufactured by United State Endoscopy Group, Inc.. The 510(k) number is K163424.

When was AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON approved by the FDA?

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON received FDA 510(k) clearance on 2017-01-04, under approval number K163424.

What company makes AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON?

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is manufactured by United State Endoscopy Group, Inc..

What is the FDA product code for AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON?

The FDA product code for AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is FEQ.

Related Devices (Code: FEQ)

K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc. K153588EndoChoice Water Bottle Cap SystemEndochoice, Inc. K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc. K173650AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc. K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States Endoscopy Group, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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