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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 the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-02-24 under 510(k) 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. The listed applicant is Endochoice, Inc.. The 510(k) number is K153588.

When did EndoChoice Water Bottle Cap System receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoChoice Water Bottle Cap System?

The FDA 510(k) record lists Endochoice, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Endochoice, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160275Fuse Endoscopic System with FuseBox ProcessorK161482EndoChoice Water Bottle Cap Irrigation SystemK161167Seal Single-Use Biopsy ValveK160403SmartStart Air/Water and Suction ValvesK151475EndoChoice Select Injection Needle

Related Devices (Code: FEQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220395EndoGator Endoscopy Irrigation TubingSTERIS CorporationK191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States 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.K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONUnited State Endoscopy Group, Inc.K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, 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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