da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170641 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 S/Si Endoscopes and da Vinci Xi Endoscopes are computer-controlled surgical instruments. These devices are designed to provide visualization during surgical procedures.
These endoscopes are manufactured by Intuitive Surgical, Inc. and have received FDA 510(k) clearance. They are categorized under the gastroenterology and urology medical 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 Xi Robotic Surgical System | Intuitive, Da Vinci Xi - Intuitive Surgical - PDF Catalogs | Technical Documentation, da Vinci S - Intuitive
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170641 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K170641 24 fields · synced Sep 26, 2026