Intuitive Surgical, Inc. · Class II · Cleared Dec 2, 2025
| K-number | K252069 |
| Device name | da Vinci SP Surgical System (SP1098) |
| Applicant | Intuitive Surgical, Inc. |
| Product code | NAY |
| Device class | Class II |
| Decision date | Dec 2, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The da Vinci SP Surgical System (Model SP1098) is a robotic-assisted endoscopic surgical system designed to enable minimally invasive surgery through a single port. It assists trained physicians in performing urologic, colorectal, general thoracoscopic, and transoral otolaryngology procedures, as well as cholecystectomy, inguinal hernia repair, and appendectomy. The system consists of a surgeon console with hand controls, a vision cart with imaging equipment, and a patient cart with instrument arms that manipulate endoscopes and surgical instruments.
The da Vinci SP Surgical System is unchanged from the predicate device (K243714) in design, performance, and technological characteristics. This submission is solely a labeling modification to add cholecystectomy, inguinal hernia repair, and appendectomy procedures to the indications for use and Professional Instructions for Use. No hardware, software, or functional modifications were made to the device.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov