Submission Details
| 510(k) Number | K243789 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
LIBERTY Endovascular Robotic System (LIBERTYOS)
Sep 2025
Decision
269d
Days
Class 2
Risk
About This 510(k) Submission
K243789 is an FDA 510(k) clearance for the LIBERTY Endovascular Robotic System (LIBERTYOS), a System, Catheter Control, Steerable (Class II — Special Controls, product code DXX), submitted by Microbot Medical , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on September 4, 2025, 269 days after receiving the submission on December 9, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.
Device Classification
| Product Code | DXX — System, Catheter Control, Steerable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1290 |
Manufacturer
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