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Anovo Surgical System (Surgeon Console, RCU and cables)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Anovo Surgical System (Surgeon Console, RCU and cables) FDA UDI
- Generic Name
- Endoscopic electromechanical surgical system FDA UDI
- Device Name
- 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 composed of Anovo Surgeon Console, two sterile instruments (Anovo 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]. Anovo Surgeon Console (UDI # 07290018151013) packed with its power cable (UDI # 07290018151037), Robotic Control Unit (RCU) (UDI # 07290018151044) and Unit Cables (UDI # 07290018151051) FDA UDI
- Model / Reference
- - FDA UDI
- 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 composed of Anovo Surgeon Console, two sterile instruments (Anovo 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]. Anovo Surgeon Console (UDI # 07290018151013) packed with its power cable (UDI # 07290018151037), Robotic Control Unit (RCU) (UDI # 07290018151044) and Unit Cables (UDI # 07290018151051) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290018151263 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 Surgical System (Surgeon Console, RCU and cables) by Momentis Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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 c70e824f-abde-401b-9d19-c00d6d100304 35 fields · synced Jun 8, 2026