Identity
- Trade Name
- Anovo Robotic Control Unit 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 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. 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 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. FDA UDI
Identifiers
- Catalog Number
- FP-02-0003 FDA UDI
- Primary DI / UDI-DI
- 07290018151310 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 Robotic Control Unit by Momentis Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic electromechanical surgical system.
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- HandX Needle Holder 5mm — Human Xtensions , Ltd. · Class II
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 65effc07-6ad9-49d7-9e4d-d8c94eb91a18 34 fields · synced May 29, 2026