da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202571 FDA 510(k)
- FDA Product Code
- NAY FDA 510(k)
- Models / Variants
- SP1098 FDA 510(k)EndoWrist SP Instruments FDA 510(k)Accessories 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, Model SP1098, is a computer-controlled surgical system that includes EndoWrist SP Instruments and accessories. This system is designed for use in surgical procedures, particularly in gastroenterology and urology specialties. It provides surgeons with enhanced precision and control during minimally invasive operations.
The system is supplied as a complete unit with various instruments and accessories. It is a reusable device that requires appropriate storage and maintenance. The da Vinci SP Surgical System has received FDA 510(k) clearance with product code NAY and is regulated under number 876.1500.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202571 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K202571 24 fields · synced Sep 23, 2026