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FDA 510(k)

Disposable Endoscope Valves System

K-Number: K232244 · 2023-11-29

ApplicantChangzhou Endoclean Medical Device Co., Ltd.
Decision Date2023-11-29
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscope Valves System is a medical device manufactured by Changzhou Endoclean Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-11-29 under approval number K232244. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Endoscope Valves System?

Disposable Endoscope Valves System is a medical device that received FDA 510(k) clearance on 2023-11-29. It is manufactured by Changzhou Endoclean Medical Device Co., Ltd.. The 510(k) number is K232244.

When was Disposable Endoscope Valves System approved by the FDA?

Disposable Endoscope Valves System received FDA 510(k) clearance on 2023-11-29, under approval number K232244.

What company makes Disposable Endoscope Valves System?

Disposable Endoscope Valves System is manufactured by Changzhou Endoclean Medical Device Co., Ltd..

What is the FDA product code for Disposable Endoscope Valves System?

The FDA product code for Disposable Endoscope Valves System is ODC.

Related Clinical Trials

NCT07596394 A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy). RECRUITING NCT07228117 GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes RECRUITING NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING NCT06510855 DurAVR™ THV EU-EFS ACTIVE_NOT_RECRUITING NCT07539701 An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy NOT_YET_RECRUITING NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Other Devices by Changzhou Endoclean Medical Device Co., Ltd.

K221310Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing K221331Disposable Endoscope Valves System

Related Devices (Code: ODC)

K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc. K162142Accessory Irrigation AdapterWilson-Cook Medical, Inc. K181712San Antonio StopcockCook Incorporated K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterCook Incorporated K192258Disposable Valve SetsZhejiang Chuangxiang Medical Technology Co., Ltd. K192059Bio Guard Air/Water & Suction ValvesUnited 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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