FDA.reportPublic FDA data

Anovo Instrument ARM Hook Electrode

Primary DI
17290018151331
Brand
Anovo Instrument ARM Hook Electrode
Company
MOMENTIS SURGICAL LTD
Model
-
Catalog number
FP-01-0004
Device description
The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMs during laparoscopic-assisted transvaginal and transabdominal benign surgical procedures. The Instrument ARM is a single-use sterile component that enables the operation and manipulation of the tissue to perform surgical tasks. The system utilizes two Instrument ARMs to perform a surgical procedure. The Instrument ARM Hook Electrode end effector enables operation and manipulation of tissue, including dissecting, coagulating, and cutting tissue using monopolar electrosurgical energy.
Published
2026-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
K243182000
K251056000
K251761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243182000Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook ElectrodeMomentis Surgical , Ltd.2025-02-03QNM
K251056000Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeMomentis Surgical , Ltd.2025-05-02QNM
K251761000Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeMomentis Surgical , Ltd.2025-07-08QNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290018151331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001815133117290018151331

GMDN Terms#

Term, Definition table
TermDefinition
Robotic endoscopic electrosurgical instrument, bipolar/monopolarAn electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in both a bipolar and monopolar configuration from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It includes a long thin body with a proximal housing intended to attach to the robotic arm, and includes the distal bipolar/monopolar electrodes in a variety of forms (e.g., forceps, hook, tip). This is a single-use device.

Regulatory Flags#

DUNS number
600482439
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290018151348Anovo Instrument ARM Curved Scissors-FP-01-00052026-04-06
17290018151096AnovoTM Instrument ARMS-FP-01-00012021-10-07
07290018151310Anovo Robotic Control Unit20FP-02-00032025-03-11
07290018151303Anovo Surgeon Console20FP-03-00032025-03-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07290018151303Anovo Surgeon ConsoleMOMENTIS 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