K250442 is an FDA 510(k) clearance for the da Vinci Surgical System, IS5000, a System, Surgical, Computer Controlled Instrument (Class II — Special Controls, product code NAY), submitted by Intuitive Surgical, Inc. (Suunyvale, US). The FDA issued a Cleared decision on July 29, 2025, 165 days after receiving the submission on February 14, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K250442 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 2025 |
| Decision Date | July 29, 2025 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NAY — System, Surgical, Computer Controlled Instrument |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |