Anovo Robotic Control Unit (RCU)

Basic Information

• Brand Name: Anovo Robotic Control Unit (RCU)
• Primary DI: 07290018151044
• Version / Model: -
• Catalog Number: FP-02-0003
• 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: b77cc7aa-245a-4154-a87d-96b38e25639d

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 comprises Anovo Surgeon Console, two sterile instruments (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 Robotic Control Unit includes two Robotic Control Units permanently attached to each other by Momentis Surgical (cannot be separated by user). Robotic Control Unit contains brushed motors, sensors, drivers and the electronic board required to drive the Instrument ARMS. Each Robotic Control Unit drives one Arm. The two Robotic Control Units are mirrored and identical except for that the right Robotic Control Unit (RCU I) includes an adaptor that enables mounting of the Robotic Control Units Assembly to the Robotic Control Support System and a mechanism that controls the linear movement of the Robotic Control Units and Instrument ARM. The Robotic Control Units connect the Instrument ARMS to an electrosurgical generator.

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	07290018151044	GS1
Package	17290018151041	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