LIBERTY Endovascular Robotic System (LIBERTYOS)— 510(k) K243789

Name: FDA 510(k) clearance K243789
Creator: U.S. Food and Drug Administration
Published: 2025-09-04

Substantially Equivalent

Microbot Medical , Ltd.

FDA 510(k) clearance K243789 for LIBERTY Endovascular Robotic System (LIBERTYOS), Substantially Equivalent on 2025-09-04. Applicant: Microbot Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Microbot Medical , Ltd.
Product code: Code DXX
Device class: Class 2
Regulation: 21 CFR 870.1290
Advisory panel: Cardiovascular
Date received: 2024-12-09
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

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