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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 a medical device manufactured by Changzhou Endoclean Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under approval 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. It is manufactured by Changzhou Endoclean Medical Device Co., Ltd.. The 510(k) number is K221310.

When was Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing approved by the FDA?

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

What company makes Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing?

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing is manufactured by Changzhou Endoclean Medical Device Co., Ltd..

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.

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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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