EndoClot— 510(k) K191254

Substantially Equivalent

Endoclot Plus Co., Ltd.

FDA 510(k) clearance K191254 for EndoClot, Substantially Equivalent on 2020-01-30. Applicant: Endoclot Plus Co., Ltd.. Device class: 2.

Clearance details

Applicant: Endoclot Plus Co., Ltd.
Product code: Code PLL
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-05-10
Decision date: 2020-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, 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.