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K Number
K243789
Device Name
LIBERTY Endovascular Robotic System (LIBERTYOS)
Manufacturer
Microbot Medical Ltd.
Date Cleared
2025-09-04

(269 days)

Product Code
DXX
Regulation Number
870.1290
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1290 Steerable catheter control system.

(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).