Identifiers
- 510(k) Number
- K170713 FDA 510(k)
- FDA Product Code
- NAY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The da Vinci Xi Surgical System is a computer-controlled surgical instrument system designed to provide flexibility for procedures performed across multiple specialties. It offers broader anatomical access and enhanced ease of use with advanced 3DHD vision and wristed instruments in a modular, adaptable format.
The system is supplied as a reusable device and is intended for use in various surgical settings. It has received FDA 510(k) clearance as substantially equivalent and is classified under product code NAY for gastroenterology and urology specialties.
Frequently asked questions
What is the da Vinci Xi Surgical System used for?
The da Vinci Xi Surgical System is a computer-controlled surgical instrument system designed to provide flexibility for procedures performed across multiple specialties, offering broader anatomical access and enhanced ease of use.
How is the da Vinci Xi Surgical System supplied?
The system is supplied as a reusable device and is intended for use in various surgical settings. It comes in a modular, adaptable format to accommodate different procedural needs.
What regulatory clearance has the da Vinci Xi Surgical System received?
The da Vinci Xi Surgical System has received FDA 510(k) clearance as substantially equivalent and is classified under product code NAY for gastroenterology and urology specialties.
What are the key features of the da Vinci Xi Surgical System?
The system features advanced 3DHD vision and wristed instruments that provide enhanced precision and control during surgical procedures. Its modular design allows for broader anatomical access across multiple specialties.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Da Vinci Xi Robotic Surgical System | Intuitive, Da Vinci Robotic Surgical Systems | Intuitive, Da Vinci Xi - Intuitive Surgical - PDF Catalogs | Technical Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170713 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K170713 24 fields · synced Sep 26, 2026