Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing— 510(k) K221310

Name: FDA 510(k) clearance K221310
Creator: U.S. Food and Drug Administration
Published: 2022-10-07

Substantially Equivalent

Changzhou Endoclean Medical Device Co., Ltd.

FDA 510(k) clearance K221310 for Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing, Substantially Equivalent on 2022-10-07. Applicant: Changzhou Endoclean Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Changzhou Endoclean Medical Device Co., Ltd.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-05-05
Decision date: 2022-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.