Intuitive Surgical Da Vinci S Surgical System With Da Vinci Connect & Da Vinci …
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101581 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 Intuitive Surgical Da Vinci S Surgical System with Da Vinci Connect & Da Vinci Onsite, Model IS2000 is a computer-controlled surgical instrument system. It is substantially equivalent to predicate devices and classified under regulation number 876.1500 with product code NAY.
This system is intended for use in gastroenterology and urology procedures. It is supplied as a reusable system requiring appropriate cleaning and sterilization between uses, and is authorized under FDA 510(k) clearance K101581.
Frequently asked questions
What is the Intuitive Surgical Da Vinci S Surgical System with Da Vinci Connect & Da Vinci Onsite, Model IS2000 intended for?
This system is intended for use in gastroenterology and urology procedures, as stated in the device description. It is a computer-controlled surgical instrument system designed to assist surgeons during these specific types of operations.
How is the Da Vinci S Surgical System supplied and maintained for use?
The system is supplied as a reusable system that requires appropriate cleaning and sterilization between uses, as specified in the device description. It is not intended for single-use and must be reprocessed according to validated procedures to ensure safety and functionality.
What regulatory pathway was used for the authorization of this device?
The device was authorized under FDA 510(k) clearance, specifically K101581, as indicated in the AUTHORIZATIONS and DESCRIPTION fields. It was found substantially equivalent to predicate devices under regulation number 876.1500 with product code NAY.
Is the Da Vinci S Surgical System a sterile device when supplied?
No, the system is not supplied sterile. It is a reusable system that requires cleaning and sterilization between uses, meaning sterility must be achieved by the user prior to each procedure through appropriate reprocessing methods.
What classification and product code apply to this surgical system?
The device is classified as a Class II medical device under regulation number 876.1500 with product code NAY, as confirmed in the openfda section and DESCRIPTION field. This classification reflects its risk level and regulatory requirements for computer-controlled surgical instrument systems.
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: Intuitive Surgical Da Vinci S Surgical System With Da Vinci Connect ..., Da Vinci Robotic Surgical Systems | Intuitive, Da Vinci Robotic Surgical Systems | Intuitive
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101581 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K101581 24 fields · synced Sep 19, 2026