FDA.reportPublic FDA data

Anovo Surgeon Console

Primary DI
07290018151303
Brand
Anovo Surgeon Console
Company
MOMENTIS SURGICAL LTD
Model
20
Catalog number
FP-03-0003
Device description
The Anovo Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic procedures. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Pedestal, and Vaginal Access Kit). The Surgeon Console is the main Human Machine Interface (HMI) for the Anovo Surgical System and provides complete control over the Instrument ARMS through the RCU, by manipulating the ARMS Controllers and Flex Controls. It is located in the non-sterile area of the Operating Room.
Published
2025-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QNMMountable Electromechanical Surgical System For Transluminal Approaches

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNMMountable Electromechanical Surgical System For Transluminal ApproachesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242157000Anovo Surgical System (Model 6Ne)Momentis Surgical , Ltd.2024-10-21QNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290018151393PackageGS11In Commercial Distribution
07290018151303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001815139317290018151393
07290018151303072900181513037290018151303

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electromechanical surgical systemAn assembly of mains electricity (AC-powered) electromechanical devices designed to be used to perform an endoscopic surgical procedure (e.g., laparoscopy) via hand-held rigid endoscopic instruments that have motor-driven articulating and mechanically-operated tips intended to facilitate surgical dexterity. It typically consists of a control unit that provides power via connecting cables to individual handpieces (handles) and several interchangeable endoscopic instruments with tip articulation (e.g., roll, yaw) for performing tissue manipulation, ligation, suturing, and cutting. The system is connected to a visual display unit (VDU) and is typically mounted on a trolley (cart) for mobility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600482439
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290018151331Anovo Instrument ARM Hook Electrode-FP-01-00042026-04-06
17290018151348Anovo Instrument ARM Curved Scissors-FP-01-00052026-04-06
07290018151310Anovo Robotic Control Unit20FP-02-00032025-03-11
07290018151297Anovo Pedestal1.00.000FP-05-00022025-03-25
17290018151355Anovo Pedestal1.00.000FP-05-00022025-03-25
07290018151037Anovo Power Cable-OS-04-00022021-10-07
07290018151112Anovo RCUSS Fixator-AS-04-00582021-10-07
07290018151129Anovo RCUSS Extension Rail-AS-04-00572021-10-07
07290018151136Anovo Sterile Drape for Robotic Control Unit, bottom-FP-04-00012021-10-07
07290018151143Anovo Sterile Drape for Robotic Control Unit, top-FP-04-00072021-10-07
07290018151167Anovo Cannula Obturator Needle-AS-04-00052021-10-07
07290018151181Anovo Mini Introducer-AS-04-00422021-10-07
07290018151204Anovo Vaginal Access Fixator-AS-04-00622021-10-07
07290018151211Anovo Cannula Short-MP-04-05472021-10-07
07290018151235Anovo ARMS Entry Guide -MP-04-05692021-10-07
07290018151242Anovo Cannula Long-MP-04-05482021-10-07
07290018151013Anovo Surgeon Console10FP-03-00032021-10-07
07290018151044Anovo Robotic Control Unit (RCU)-FP-02-00032021-10-07
07290018151051Anovo Unit Cable-FP-04-00042021-10-07
07290018151174Anovo Cannula Connector-AS-04-00362021-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17290018151331Anovo Instrument ARM Hook ElectrodeMOMENTIS SURGICAL LTDQNM2026-04-06
17290018151348Anovo Instrument ARM Curved ScissorsMOMENTIS SURGICAL LTDQNM2026-04-06
00836230005092Anovo MULTI-PORT STERILE DRAPEPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.QNM2026-03-15
07290018151297Anovo PedestalMOMENTIS SURGICAL LTDQNM2025-03-25
17290018151355Anovo PedestalMOMENTIS SURGICAL LTDQNM2025-03-25
07290018151310Anovo Robotic Control UnitMOMENTIS SURGICAL LTDQNM2025-03-11
17290018151324Anovo Robotic Control UnitMOMENTIS SURGICAL LTDQNM2025-03-11
07290018151037Anovo Power CableMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151112Anovo RCUSS FixatorMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151129Anovo RCUSS Extension RailMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151136Anovo Sterile Drape for Robotic Control Unit, bottomMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151143Anovo Sterile Drape for Robotic Control Unit, topMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151167Anovo Cannula Obturator NeedleMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151181Anovo Mini IntroducerMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151204Anovo Vaginal Access FixatorMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151211Anovo Cannula ShortMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151235Anovo ARMS Entry Guide MOMENTIS SURGICAL LTDQNM2021-10-07
07290018151242Anovo Cannula LongMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151013Anovo Surgeon ConsoleMOMENTIS SURGICAL LTDQNM2021-10-07
17290018151034Hominis® Power CableMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
07290018151044Anovo Robotic Control Unit (RCU)MOMENTIS SURGICAL LTDQNM2021-10-07
07290018151051Anovo Unit CableMOMENTIS SURGICAL LTDQNM2021-10-07
17290018151119Hominis® RCUSS FixatorMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
17290018151126Hominis® RCUSS Extension RailMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
17290018151133HOMINIS® Sterile Drape for Robotic Control Unit, bottomMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
17290018151140Hominis® Sterile Drape for Robotic Control Unit, topMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
17290018151164Hominis® Cannula Obturator NeedleMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
07290018151174Anovo Cannula ConnectorMOMENTIS SURGICAL LTDQNM2021-10-07
17290018151188Hominis® Mini IntroducerMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
07290018151198Anovo Blunt Cannula ObturatorMOMENTIS SURGICAL LTDQNM2021-10-07