Ligation Device— 510(k) K172985

Substantially Equivalent

Leo Medical Co., Ltd.

FDA 510(k) clearance K172985 for Ligation Device, Substantially Equivalent on 2018-06-14. Applicant: Leo Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Leo Medical Co., Ltd.
Product code: Code FHN
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2017-09-27
Decision date: 2018-06-14
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.