510(k) K232610 ยท NAY System, Surgical, Computer Controlled Instrument
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 14, 2024 |
| Received | Aug 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2026 | Intuitive Surgical, Inc. Brand Name: Da Vinci 5
Product Name: ASSY,DV5 TOWER,IS5000
Model/Catalog Number: 380746
Software Version: N/A
Product Description: Preface:
This report under 21 CFR 806.10 is being submitted for the Open, Classified |
NAY | None listed |
| Feb 18, 2026 | Intuitive Surgical, Inc. Da Vinci 5
ASSY, DV5 CONSOLE, IS5000
Model/Catalog Number: 380730
Used for minimally invasive surgery. Open, Classified |
NAY | None listed |
| Feb 12, 2026 | Intuitive Surgical, Inc. da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 Open, Classified |
NAY | None listed |
| Feb 2, 2026 | Intuitive Surgical, Inc. Brand Name: Da Vinci
Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System
Model/Catalog Number: IS4000; IS4200; IS5000
Software Version: N/A
Product Description: The da Vinci Xi Open, Classified |
NAY | None listed |
| Dec 19, 2025 | Intuitive Surgical, Inc. da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40 Open, Classified |
NAY | None listed |
| Mar 12, 2025 | Intuitive Surgical, Inc. Brand Name: Da Vinci 5
Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals
Model/Catalog Number: 380730
Software Version: N/A
.
Refer to HHE for additional details.
Component: N/A Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.