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FDA 510(k)

EndoChoice Water Bottle Cap System

K-Number: K153588 · 2016-02-24

ApplicantEndochoice, Inc.
Decision Date2016-02-24
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoChoice Water Bottle Cap System is a medical device manufactured by Endochoice, Inc.. It received FDA 510(k) clearance on 2016-02-24 under approval number K153588. 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 EndoChoice Water Bottle Cap System?

EndoChoice Water Bottle Cap System is a medical device that received FDA 510(k) clearance on 2016-02-24. It is manufactured by Endochoice, Inc.. The 510(k) number is K153588.

When was EndoChoice Water Bottle Cap System approved by the FDA?

EndoChoice Water Bottle Cap System received FDA 510(k) clearance on 2016-02-24, under approval number K153588.

What company makes EndoChoice Water Bottle Cap System?

EndoChoice Water Bottle Cap System is manufactured by Endochoice, Inc..

What is the FDA product code for EndoChoice Water Bottle Cap System?

The FDA product code for EndoChoice Water Bottle Cap System is FEQ.

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Other Devices by Endochoice, Inc.

K160275Fuse Endoscopic System with FuseBox Processor K161482EndoChoice Water Bottle Cap Irrigation System K161167Seal Single-Use Biopsy Valve K160403SmartStart Air/Water and Suction Valves K151475EndoChoice Select Injection Needle

Related Devices (Code: FEQ)

K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. K161482EndoChoice Water Bottle Cap Irrigation 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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