Anovo Surgeon Console

Basic Information

• Brand Name: Anovo Surgeon Console
• Primary DI: 07290018151013
• Version / Model: 10
• Catalog Number: FP-03-0003
• Company Name: MOMENTIS SURGICAL LTD
• Labeler DUNS: 600482439
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-07
• Public Version: 4
• Public Version Date: 2022-07-29
• Public Version Status: Update
• Public Device Record Key: 11a2b1dc-be15-4cb9-9708-112f50640a7b

Device Description

The AnovoTM 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 Surgeon Console comprised of Arm Controllers (Joysticks and Thumbsticks), an Adjustable Controllers Stand, a PC with Touch Screen, Manual Release Tool and the Power Adapter, and allowing the operating surgeon to operate the Anovo Instrument Arms. There are two sets of Arm Controllers for the Anovo System: two Thumbsticks and two ARMS Controllers. The ARMS Controllers are enabled only when the system is at “resume” state and allow for the accurate control of the Anovo Instrument ARMS during the surgical procedure. Like the Anovo Instrument Arm, each ARMS Controllers has three joints: wrist, elbow and shoulder, so that each Anovo Instrument ARM moves accordingly to Controller's movement. The surgeon-held Controller handle is above the elbow joint and allows for multiple functionality transitions.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	General, Plastic Surgery	878.4961	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58137	Endoscopic electromechanical surgical system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290018151013	GS1
Package	17290018151010	GS1		1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius