510(k) K171294 ยท NAY System, Surgical, Computer Controlled Instrument
da Vinci X Surgical System
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 26, 2017 |
| Received | May 2, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171294
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Intuitive Surgical, Inc. Brand Name: Da Vinci X and Da Vinci Xi
Product Name: da Vinci X, Xi Surgical System
Model/Catalog Number: IS4000; IS4200
Software Version: N/A
Product Description: he da Vinci Xi, X Surgical systems 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 |
| Mar 28, 2023 | Intuitive Surgical, Inc. da Vinci Xi Surgical System Model IS4000
da Vinci X Surgical System Model IS4200 Open, Classified |
NAY | None listed |
| Mar 16, 2023 | Intuitive Surgical, Inc. Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200;
Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci X Open, Classified |
NAY | None listed |
| Oct 25, 2022 | Intuitive Surgical, Inc. da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS) Open, Classified |
NAY | None listed |
| Jul 26, 2019 | Intuitive Surgical, Inc. da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures. Terminated |
NAY | None listed |
| Apr 11, 2019 | Intuitive Surgical Inc da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC) Terminated |
NAY | None listed |
| Nov 21, 2018 | Intuitive Surgical, Inc. da Vinci X Surgical System Terminated |
NAY | None listed |
| Jul 16, 2018 | Intuitive Surgical, Inc. da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units
The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope Terminated |
NAY | None listed |
| Mar 7, 2018 | Intuitive Surgical, Inc. da Vinci X Surgical System, Model IS4200.
Product Usage:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate con Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.