Anovo Surgeon Console FP-03-0003

GUDID 07290018151303

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 composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Pedestal, and Vaginal Access Kit). The Surgeon Console is the main Human Machine Interface (HMI) for the Anovo Surgical System and provides complete control over the Instrument ARMS through the RCU, by manipulating the ARMS Controllers and Flex Controls. It is located in the non-sterile area of the Operating Room.

MOMENTIS SURGICAL LTD

Endoscopic electromechanical surgical system

• Primary Device ID: 07290018151303
• NIH Device Record Key: d326555e-327d-40fb-9b08-bf32d1511222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anovo Surgeon Console
• Version Model Number: 20
• Catalog Number: FP-03-0003
• 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	07290018151303 [Primary]
GS1	17290018151393 [Package]; 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: 2025-03-19The 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 composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Pedestal, and Vaginal Access Kit). The Surgeon Console is the main Human Machine Interface (HMI) for the Anovo Surgical System and provides complete control over the Instrument ARMS through the RCU, by manipulating the ARMS Controllers and Flex Controls. It is located in the non-sterile area of the Operating Room.
• 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: 2025-03-19 The Anovo Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipu