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FDA 510(k)

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM

K-Number: K191559 · 2019-08-01

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2019-08-01
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is a medical device manufactured by United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2019-08-01 under approval number K191559. 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 CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM?

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is a medical device that received FDA 510(k) clearance on 2019-08-01. It is manufactured by United States Endoscopy Group, Inc.. The 510(k) number is K191559.

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

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM received FDA 510(k) clearance on 2019-08-01, under approval number K191559.

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

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is manufactured by United States Endoscopy Group, Inc..

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

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

Other Devices by United States Endoscopy Group, Inc.

K172805gi-4000 Electrosurgical Generator K163495AdvanCE capsule endoscope delivery device K163492Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear K182909Roth Net Retriever Product Line K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm K173650AquaShield System CO2- Fujifilm

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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. K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONUnited State Endoscopy Group, Inc. K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc. K173650AquaShield 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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