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FDA 510(k)

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing

K-Number: K221310 · 2022-10-07

ApplicantChangzhou Endoclean Medical Device Co., Ltd.
Decision Date2022-10-07
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing 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 2022-10-07 under 510(k) number K221310. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing?

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Changzhou Endoclean Medical Device Co., Ltd.. The 510(k) number is K221310.

When did Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing receive FDA 510(k) clearance?

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221310.

Who is the listed applicant for Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing?

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 Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing?

The FDA product code for Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing is OCX.

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

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K232244Disposable Endoscope Valves SystemK221331Disposable Endoscope Valves System

Related Devices (Code: OCX)

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.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, Inc.

Official Source

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