da Vinci Xi Surgical System, da Vinci X Surgical System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191529 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 and X Surgical Systems are robotic surgical platforms designed for minimally invasive procedures. These systems combine computer-controlled instrumentation with high-definition 3D visualization to enable surgeons to perform complex operations with enhanced precision, dexterity, and control. They are classified as computer-controlled surgical instruments and are intended for use across multiple specialties, including gastroenterology and urology. The systems feature wristed instruments and advanced imaging to facilitate intricate maneuvers in confined spaces.
These systems are supplied as modular, reusable surgical platforms intended for use in operating rooms. They are not single-use devices and require proper maintenance, calibration, and sterilization protocols as outlined by the manufacturer. The da Vinci Xi and X systems are regulated under the FDA’s 510(k) pathway, with clearance granted for substantial equivalence to prior generations of robotic surgical systems. They are not MRI-compatible and must be used in environments where electromagnetic interference is controlled. Each system includes multiple instrument ports and accessories, with configurations tailored for specific surgical approaches.
Frequently asked questions
What specialties are the da Vinci Xi and X Surgical Systems primarily used for according to their regulatory submissions?
The da Vinci Xi and X Surgical Systems are primarily associated with procedures in gastroenterology and urology, as indicated by their advisory committee descriptions in the FDA submissions. These systems are designed to support minimally invasive surgeries across these specialties, leveraging advanced imaging and robotic instrumentation for enhanced precision.
Are the da Vinci Xi and X Surgical Systems single-use or reusable, and what maintenance is required?
The da Vinci Xi and X Surgical Systems are not single-use devices—they are modular, reusable surgical platforms intended for repeated use in operating rooms. Proper maintenance, calibration, and sterilization protocols must be followed as outlined by Intuitive Surgical to ensure safe and effective operation. The systems require specialized care due to their complex instrumentation and electromagnetic components.
Can the da Vinci Xi or X Surgical System be used in an MRI environment, and why?
No, the da Vinci Xi and X Surgical Systems are not MRI-compatible. The data explicitly states they must be used in environments where electromagnetic interference is controlled, as their operation could be disrupted or pose risks in MRI settings. This restriction is critical for patient safety and system integrity.
How are the da Vinci Xi and X Surgical Systems regulated in the U.S., and what does that mean for buyers?
The systems are regulated under the FDA’s 510(k) pathway, with clearance granted for substantial equivalence to prior generations of robotic surgical systems. This means buyers can rely on the FDA’s determination that the systems meet the same safety and effectiveness standards as their predecessors, though they should still adhere to manufacturer guidelines for proper use, maintenance, and compliance.
What types of surgical approaches or configurations are available with the da Vinci Xi and X systems?
The systems include multiple instrument ports and accessories, with configurations tailored for specific surgical approaches. While exact configurations aren’t detailed in the data, the modular design allows for flexibility in adapting to procedures in gastroenterology and urology, enabling intricate maneuvers in confined spaces through wristed instruments and high-definition 3D visualization.
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 X Robotic Surgical System | Intuitive, Da Vinci Xi Robotic Surgical System | Intuitive, Comparing the da Vinci X and da Vinci Xi: What Hospitals Need to Know
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191529 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical
Sources (1)
- FDA 510(k) K191529 24 fields · synced Oct 6, 2026