Intuitive Surgical, Inc. · Class II · Cleared Sep 10, 2025
| K-number | K251817 |
| Device name | da Vinci SP Surgical System (SP1098) |
| Applicant | Intuitive Surgical, Inc. |
| Product code | NAY |
| Device class | Class II |
| Decision date | Sep 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The da Vinci SP Surgical System (SP1098) is a robotically-assisted surgical device consisting of a Surgeon Console, Vision Cart, and Patient Cart that enables minimally-invasive surgery. It is intended to assist in accurate control of EndoWrist SP Instruments during urologic, colorectal, general thoracoscopic, and transoral otolaryngology procedures (benign tumors and T1-T2 malignant tumors) for adult patients in operating room environments.
The subject device includes modified software with a new feature called 'Surgeon Cloud Accounts' that allows the da Vinci SP Surgical System to communicate with a network of servers, databases, and data storage solutions. The existing dedicated network processor allocated for networking tasks is extended to secure surgeon cloud accounts while maintaining security isolation from critical surgical system operation.
Not stated in this summary.
The subject device has identical indications for use as the predicate device (K243714, da Vinci SP Surgical System). The technological changes are limited to modified software adding cloud account functionality with no changes to the core surgical system design. Verification and validation testing including software, cybersecurity, and clinical validation confirmed no safety or effectiveness issues or unexpected risks were identified, and human factors evaluation demonstrated the device is safe and effective for its intended use and users.
View the full FDA submission: accessdata.fda.gov