K243789 is an FDA 510(k) clearance for the LIBERTY Endovascular Robotic System (LIBERTYOS). Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.
Submitted by Microbot Medical , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on September 4, 2025 after a review of 269 days - an extended review cycle.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Microbot Medical , Ltd. devices
NCT06141694
Completed
Interventional
Industry-sponsored
Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.
Assessment of Clinical Capabilities of LIBERTY® Endovascular Robotic System's Performance and Safety in Peripheral Vascular Interventions: A Multi-Center, Single Arm, Prospective Trial (ACCESS-PVI)
| Condition studied |
Peripheral Vascular Interventions |
| Study design |
Single group |
| Eligibility |
All sexes
· 22 Years+
|
| Sponsor |
Microbot Medical, INC
(industry)
|
Started 2024-07-02
→
Primary completion 2024-10-10
→
Completed 2024-10-15
Primary outcome
Effectiveness Endpoint
Secondary outcome
Safety Endpoint
Study completed - no results published.
This trial concluded in 2024 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov