Wellead Endoscopic Seal— 510(k) K211814

Name: FDA 510(k) clearance K211814
Creator: U.S. Food and Drug Administration
Published: 2022-01-14

Substantially Equivalent

Well Lead Medical Co., Ltd.

FDA 510(k) clearance K211814 for Wellead Endoscopic Seal, Substantially Equivalent on 2022-01-14. Applicant: Well Lead Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Well Lead Medical Co., Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-11
Decision date: 2022-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, 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.