da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) (K240852)
Description
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) by Intuitive Surgical, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240852
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) (K240852) cites 12 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical S... | Intuitive Surgical, Inc. | 2023 |
| K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical ... | Intuitive Surgical, Inc. | 2022 |
| K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical S... | Intuitive Surgical, Inc. | 2021 |
| K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical S... | Intuitive Surgical, Inc. | 2020 |
| K183086 | da Vinci X and Xi Surgical System | Intuitive Surgical, Inc. | 2020 |
| K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018 |
| K173585 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018 |
| K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018 |
| K172643 | da Vinci Xi Surgical System; da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018 |
| K171632 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2017 |
| K170713 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2017 |
| K171294 | da Vinci X Surgical System | Intuitive Surgical, Inc. | 2017 |
Trace the full predicate network for K240852
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.