Anovo Robotic Control Unit FP-02-0003

GUDID 17290018151324

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 comprises Anovo Surgeon Console, two sterile instruments (Instrument ARMS), Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Pedestal 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 Robotic Control Unit is mounted on the Pedestal.

MOMENTIS SURGICAL LTD

Endoscopic electromechanical surgical system

• Primary Device ID: 17290018151324
• NIH Device Record Key: 65effc07-6ad9-49d7-9e4d-d8c94eb91a18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anovo Robotic Control Unit
• Version Model Number: 20
• Catalog Number: FP-02-0003
• Company DUNS: 600482439
• Company Name: MOMENTIS SURGICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018151310 [Primary]
GS1	17290018151324 [Package]; Contains: 07290018151310; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242157

FDA Product Code

• QNM: Mountable Electromechanical Surgical System For Transluminal Approaches

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-19
• Device Publish Date: 2025-03-11

Devices Manufactured by MOMENTIS SURGICAL LTD

• 17290018151355 - Anovo Pedestal: 2025-04-02 The Pedestal is an accessory to the Anovo Surgical System which supports the RCU during the surgical procedure. The Pedestal is
• 07290018151303 - Anovo Surgeon Console: 2025-03-19 The Anovo Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipu
• 17290018151324 - Anovo Robotic Control Unit: 2025-03-19The 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 comprises Anovo Surgeon Console, two sterile instruments (Instrument ARMS), Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Pedestal 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 Robotic Control Unit is mounted on the Pedestal.
• 17290018151324 - Anovo Robotic Control Unit: 2025-03-19 The Anovo Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipu