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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 the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Endoclean Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-11-29 under 510(k) 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. The listed applicant is Changzhou Endoclean Medical Device Co., Ltd.. The 510(k) number is K232244.

When did Disposable Endoscope Valves System receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Endoscope Valves System?

The FDA 510(k) record lists Changzhou Endoclean Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Changzhou Endoclean Medical Device Co., Ltd. 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.

K221310Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingK221331Disposable Endoscope Valves System

Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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