Intuitive Surgical, Inc. · Class II · Cleared Jan 16, 2026
| K-number | K253556 |
| Device name | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator |
| Applicant | Intuitive Surgical, Inc. |
| Product code | NAY |
| Device class | Class II |
| Decision date | Jan 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The da Vinci SP Surgical System (SP1098) is a robotic-assisted surgical device designed to enable minimally-invasive surgery through a single-port approach. It consists of a Surgeon Console, Vision Cart, and Patient Cart and is used for urologic, colorectal, general thoracoscopic, and transoral otolaryngology procedures on benign and malignant tumors. The da Vinci E-200 Generator delivers high-frequency energy for cutting, coagulation, and vessel sealing during both robotic and open/laparoscopic procedures.
The key modification is the integration and replacement of the Vision Cart's Erbe VIO dV generator and standalone EnergyShield Monitoring (ESM) with the da Vinci E-200 Electrosurgical Generator, which incorporates an integrated ESM. The da Vinci E-200 Generator's software was updated to include ESM functionality for compatibility with the da Vinci SP Surgical System.
Not stated in this summary.
The indications for use are identical between the predicate and subject devices. Based on indications for use, technological characteristics, and performance data from design verification (software requirements, EMC/electrical safety, system interface, instrument compatibility, packaging/labeling) and design validation (simulated clinical use testing and human factors evaluation), the subject da Vinci SP Surgical System and da Vinci E-200 Generator are substantially equivalent to their predicate devices (K251817 and K241635).
View the full FDA submission: accessdata.fda.gov