Da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131962 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
- SESU FDA 510(k)
The Da Vinci SP Surgical System is a Computer-Controlled Surgical Instrument System designed for robotic-assisted minimally invasive surgery. It integrates robotic arms, high-definition 3D visualization, and specialized instruments to enable precise, tissue-preserving procedures in specialties such as gastroenterology and urology. The system is engineered to perform complex surgeries through a single incision or natural orifice, enhancing surgical dexterity and control.
The system is supplied as a reusable medical device, intended for use in sterile operating room environments. EndoWrist SP instruments are multiple-use endoscopic tools compatible exclusively with the Da Vinci SP system. The system is classified under FDA 510(k) clearance (K131962) and adheres to regulatory standards for surgical robotics, including MRI safety considerations for compatible accessories. Instruments are available in various sizes and configurations, as referenced by their unique FEI numbers.
Frequently asked questions
What specialties is the Da Vinci SP Surgical System primarily designed to support in robotic-assisted procedures?
The Da Vinci SP Surgical System is engineered for robotic-assisted minimally invasive surgery in gastroenterology and urology, as indicated by its advisory committee classifications and specialized design for procedures requiring precise dexterity through single-incision or natural orifice approaches.
Are the EndoWrist SP instruments single-use or reusable, and how does this affect their use in the operating room?
The EndoWrist SP instruments are multiple-use tools designed exclusively for the Da Vinci SP system. Since they are reusable, they must be properly sterilized between procedures in a sterile operating room environment to maintain safety and compliance with surgical standards.
How do I identify the specific model or size of an EndoWrist SP instrument, and why does this matter?
Each EndoWrist SP instrument is identified by its unique FEI number (e.g., 3042953929, 3039523130), which corresponds to its configuration and size. This matters because the system is designed for compatibility with these specific instruments, ensuring precise surgical control and functionality during procedures.
What regulatory pathway was followed for FDA clearance of the Da Vinci SP Surgical System, and what does this imply for its use?
The Da Vinci SP Surgical System received FDA 510(k) clearance (K131962) under a traditional review process, meaning it was deemed substantially equivalent to a legally marketed predicate device. This clearance implies the system meets FDA standards for safety and effectiveness as a computer-controlled surgical instrument system for robotic-assisted procedures.
Are there any MRI safety considerations for accessories used with the Da Vinci SP Surgical System?
Yes, the Da Vinci SP Surgical System adheres to MRI safety considerations for compatible accessories, meaning certain components or tools may be designed to be safe for use in MRI environments. However, specific accessories must be verified as MRI-compatible to avoid interference or safety risks during imaging procedures.
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: Robotic Surgical Instruments | Da Vinci | Intuitive, Single Port | Da Vinci SP | Da Vinci Systems - Intuitive Surgical, Instruments and Accessories - Intuitive
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131962 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K131962 24 fields · synced Sep 19, 2026