Identity
- Trade Name
- Anovo Surgeon Console FDA UDI
- Generic Name
- Endoscopic electromechanical surgical system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 20 FDA UDI
- 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 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. FDA UDI
Identifiers
- Catalog Number
- FP-03-0003 FDA UDI
- Primary DI / UDI-DI
- 07290018151303 FDA UDI
- FDA Product Code
- QNM FDA UDI
- GMDN Term
- Endoscopic electromechanical surgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4961 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic electromechanical surgical system
Anovo Surgeon Console by Momentis Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Momentis Surgical Ltd
Sources (1)
- FDA UDI d326555e-327d-40fb-9b08-bf32d1511222 34 fields · synced May 30, 2026