K243789 is an FDA 510(k) clearance for the LIBERTY Endovascular Robotic System (LIBERTYOS). This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.1290.
| 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 |
| Product Code | DXX - System, Catheter Control, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1290 |