da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231224 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 (IS4000) and da Vinci X Surgical System (IS4200) are computer-controlled surgical systems designed for use in gastroenterology and urology procedures. These systems provide robotic-assisted surgery with 3DHD vision and wristed instruments, enabling enhanced precision and control during minimally invasive operations.
The systems are supplied as reusable platforms intended for use in operating rooms. They are authorized under FDA 510(k) clearance (K231224) and are classified as Class II medical devices under regulation number 876.1500. The systems support standardized instrumentation across da Vinci multiport platforms and are intended for use in multiple specialties as indicated by the gastroenterology and urology advisory committee designations.
Frequently asked questions
What is the da Vinci Xi and X Surgical System intended for?
The da Vinci Xi Surgical System (IS4000) and da Vinci X Surgical System (IS4200) are computer-controlled surgical systems designed for use in gastroenterology and urology procedures, providing robotic-assisted surgery with 3DHD vision and wristed instruments to enable enhanced precision and control during minimally invasive operations.
How is the da Vinci Xi and X Surgical System supplied and used?
The systems are supplied as reusable platforms intended for use in operating rooms, meaning they are designed for repeated use after proper cleaning and sterilization between procedures, not as single-use devices.
What regulatory pathway was used for the da Vinci Xi and X Surgical System?
The da Vinci Xi Surgical System (IS4000) and da Vinci X Surgical System (IS4200) are authorized under FDA 510(k) clearance (K231224) and are classified as Class II medical devices under regulation number 876.1500.
What standardization does the da Vinci Xi and X Surgical System support?
The systems support standardized instrumentation across da Vinci multiport platforms, allowing compatibility with a range of instruments used in the da Vinci surgical ecosystem.
What advisory committee designations apply to the da Vinci Xi and X Surgical System?
The systems are associated with gastroenterology and urology advisory committee designations, which reflect the specialties for which the device was evaluated during its regulatory review, not clinical indications.
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, da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231224 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K231224 24 fields · synced Oct 6, 2026