FDA.reportPublic FDA data

AnovoTM Instrument ARMS

Primary DI
17290018151096
Brand
AnovoTM Instrument ARMS
Company
MOMENTIS SURGICAL LTD
Model
-
Catalog number
FP-01-0001
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 gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit).The Anovo Instrument ARMS are the system’s components that are inserted transvaginally into the pelvic cavity to manipulate the tissue and perform the surgery. Twoidentical Instrument ARMS are connected to the Robotic Control Units, each of which corresponds to the respective hand of the surgeon as controlled by right or leftControllers. The two Arms utilized with the Anovo System are identical and provide identical capabilities.The end effector, located at the end of the flexible section, provides grasping and electrosurgical capabilities. The Instrument Arm is a sterile disposable component. It is ETO sterilized and provided to the user within a plastic tray packaged in a sterile pouch.Instrument ARMS Packed with Cannula Seal & ARMS Entry Guide Seal
Published
2021-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
DEN190022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190022000Hominis Surgical SystemMomentis Surgical , Ltd.2021-02-26QNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290018151093PackageGS110In Commercial Distribution
17290018151096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729001815109327290018151093
1729001815109617290018151096

GMDN Terms#

Term, Definition table
TermDefinition
Robotic electrosurgical instrument, bipolar, single-useA sterile electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) 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 may include the distal bipolar electrode in one of a variety of forms (e.g., forceps, hook). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-653-9210customerservice@memicmed.com
954-653-9210customerservice@momentissurgical.com

Regulatory Flags#

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