Anovo Surgeon Console
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Basic Information
- Brand Name
- Anovo Surgeon Console
- Primary DI
- 07290018151303
- Version / Model
- 20
- Catalog Number
- FP-03-0003
- Company Name
- MOMENTIS SURGICAL LTD
- Labeler DUNS
- 600482439
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-11
- Public Version
- 3
- Public Version Date
- 2025-06-19
- Public Version Status
- Update
- Public Device Record Key
- d326555e-327d-40fb-9b08-bf32d1511222
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QNM | Mountable Electromechanical Surgical System For Transluminal Approaches | General, Plastic Surgery | 878.4961 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58137 | Endoscopic electromechanical surgical system | An assembly of mains electricity (AC-powered) electromechanical devices designed to be used to perform an endoscopic surgical procedure (e.g., laparoscopy) via hand-held rigid endoscopic instruments that have motor-driven articulating and mechanically-operated tips intended to facilitate surgical dexterity. It typically consists of a control unit that provides power via connecting cables to individual handpieces (handles) and several interchangeable endoscopic instruments with tip articulation (e.g., roll, yaw) for performing tissue manipulation, ligation, suturing, and cutting. The system is connected to a visual display unit (VDU) and is typically mounted on a trolley (cart) for mobility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018151303 | GS1 | ||||
| Package | 17290018151393 | GS1 | 1 | In Commercial Distribution |