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510(k) K243789

LIBERTY Endovascular Robotic System (LIBERTYOS) by Microbot Medical , Ltd. — Product Code DXX

K243789 is an FDA 510(k) premarket notification submitted by Microbot Medical , Ltd. for the device "LIBERTY Endovascular Robotic System (LIBERTYOS)". The FDA issued a decision of Substantially Equivalent on September 4, 2025. The device falls under product code DXX (System, Catheter Control, Steerable), a Class II device regulated under 21 CFR 870.1290.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2025
Date Received
December 9, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Catheter Control, Steerable
Device Class
Class II
Regulation Number
870.1290
Review Panel
CV
Submission Type

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  • K180517 — CorPath GRX System (March 29, 2018)
  • K173806 — CorPath GRX System (March 1, 2018)
  • K173288 — CorPath GRX System (February 15, 2018)
  • K160121 — CorPath GRX System (October 27, 2016)
  • K152999 — CorPath 200 System (March 18, 2016)
  • K150892 — CorPath 200 System (October 2, 2015)
  • K151730 — Magellan Robotic System (July 23, 2015)

FDA data resources