FDA.reportPublic FDA data

LIBERTY Endovascular Robotic System - arm

Primary DI
07290019564102
Brand
LIBERTY Endovascular Robotic System - arm
Company
MICROBOT MEDICAL LTD
Model
LIBERTYOS
Device description
LIBERTY Endovascular Robotic System - arm
Published
2025-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXXSystem, Catheter Control, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXXSystem, Catheter Control, SteerableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243789000LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical , Ltd.2025-09-04DXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019564102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019564102072900195641027290019564102

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system workstationA mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius37 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-(888) 768-1664customer.experience@microbotmedical.com

Regulatory Flags#

DUNS number
649065489
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019564003LIBERTY Endovascular Robotic SystemLIBERTYOSLAD-10-0012025-11-18
07290019564058LIBERTY Endovascular Robotic System - robotLIBERTYOS2025-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M58800101400010GenesisXStereotaxis, Inc.DXX2026-01-09
07290019564003LIBERTY Endovascular Robotic SystemMICROBOT MEDICAL LTDDXX2025-11-18
07290019564058LIBERTY Endovascular Robotic System - robotMICROBOT MEDICAL LTDDXX2025-11-18
00816280023192CorPath GRX Cassette DuoCorindus, Inc.DXX2022-08-08
00816280023185CorPath GRX Cassette DuoCORINDUS, INC.DXX2022-08-08
00816280023123CorPath GRX Extended Reach ArmCorindus, Inc.DXX2018-04-05
00816280023017CorPath GRX Control ConsoleCorindus, Inc.DXX2017-01-20
00816280023024CorPath GRX Extended Reach ArmCorindus, Inc.DXX2017-01-20
00816280023031CorPath GRX Robotic DriveCorindus, Inc.DXX2017-01-20
00816280023055CorPath GRX CassetteCorindus, Inc.DXX2017-01-20
00816280023079CorPath GRX Drive GearCorindus, Inc.DXX2017-01-20
00816280023093CorPath GRX Drape, Robotic Drive and ArmCorindus, Inc.DXX2017-01-20
00816280023116CorPath GRX Drape, Control ConsoleCorindus, Inc.DXX2017-01-20
00815671020246Sensei®HANSEN MEDICAL, INC.DXX2016-09-30
00815671020260Sensei®HANSEN MEDICAL, INC.DXX2016-09-30
00815671020284Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00815671020314Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00815671020321Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00816280022010CorPath 200 Control ConsoleCorindus, Inc.DXX2016-09-24
00816280022027CorPath 200 Articulated ArmCorindus, Inc.DXX2016-09-24
00816280022034CorPath 200 Robotic DriveCorindus, Inc.DXX2016-09-24
00816280022041CorPath 200 CassetteCorindus, Inc.DXX2016-09-24
00816280022072CorPath 200 POGO Pin CapsCorindus, Inc.DXX2016-09-24
00816280022096CorPath 200 Control Console DrapeCorindus, Inc.DXX2016-09-24
00816280022119CorPath 200 Joystick CoversCorindus, Inc.DXX2016-09-24
00816280022133CorPath 200 Robotic Drive DrapeCorindus, Inc.DXX2016-09-24
10815671020007Artisan®HANSEN MEDICAL, INC.DXX2016-09-23
10815671020083Magellan™HANSEN MEDICAL, INC.DXX2016-09-23
00815671020048Magellan™HANSEN MEDICAL, INC.DXX2016-09-23
00815671020055Magellan™HANSEN MEDICAL, INC.DXX2016-09-23