Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EndoChoice Water Bottle Cap Irrigation System

K-Number: K161482 · 2016-06-27

ApplicantEndochoice, Inc.
Decision Date2016-06-27
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoChoice Water Bottle Cap Irrigation System is a medical device manufactured by Endochoice, Inc.. It received FDA 510(k) clearance on 2016-06-27 under approval number K161482. 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 Irrigation System?

EndoChoice Water Bottle Cap Irrigation System is a medical device that received FDA 510(k) clearance on 2016-06-27. It is manufactured by Endochoice, Inc.. The 510(k) number is K161482.

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

EndoChoice Water Bottle Cap Irrigation System received FDA 510(k) clearance on 2016-06-27, under approval number K161482.

What company makes EndoChoice Water Bottle Cap Irrigation System?

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

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

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

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07601503 Evaluating In-line Chlorination in Nigeria NOT_YET_RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT05729477 A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device TERMINATED NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING

Other Devices by Endochoice, Inc.

K160275Fuse Endoscopic System with FuseBox Processor K161167Seal Single-Use Biopsy Valve K160403SmartStart Air/Water and Suction Valves K153588EndoChoice Water Bottle Cap System K151475EndoChoice Select Injection Needle

Related Devices (Code: FEQ)

K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, 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.

↑