Cleared Traditional

K243789 - LIBERTY Endovascular Robotic System (LIBERTYOS) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K243789 · Microbot Medical , Ltd. · Cardiovascular device
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Sep 2025
Decision
269d
Days
Class 2
Risk

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

Submission Details

510(k) Number K243789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2024
Decision Date September 04, 2025
Days to Decision 269 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Hogan Lovells
Lina Kontos

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
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)

20
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
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