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FDA 510(k)

Erbe’s CO2 Tubing/Cap Sets

K-Number: K162152 · 2016-08-31

ApplicantErbe USA, Inc.
Decision Date2016-08-31
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Erbe’s CO2 Tubing/Cap Sets is a medical device manufactured by Erbe USA, Inc.. It received FDA 510(k) clearance on 2016-08-31 under approval number K162152. 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 Erbe’s CO2 Tubing/Cap Sets?

Erbe’s CO2 Tubing/Cap Sets is a medical device that received FDA 510(k) clearance on 2016-08-31. It is manufactured by Erbe USA, Inc.. The 510(k) number is K162152.

When was Erbe’s CO2 Tubing/Cap Sets approved by the FDA?

Erbe’s CO2 Tubing/Cap Sets received FDA 510(k) clearance on 2016-08-31, under approval number K162152.

What company makes Erbe’s CO2 Tubing/Cap Sets?

Erbe’s CO2 Tubing/Cap Sets is manufactured by Erbe USA, Inc..

What is the FDA product code for Erbe’s CO2 Tubing/Cap Sets?

The FDA product code for Erbe’s CO2 Tubing/Cap Sets is FEQ.

Other Devices by Erbe USA, Inc.

K182444ERBEFLO Olympus Scope Port Connector K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector K190469ERBEFLO 2 Disposable Tubing System K221177Erbe's Tubing/Cap Sets

Related Devices (Code: FEQ)

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. 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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