da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K231224)
Description
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) by Intuitive Surgical, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231224
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 Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K231224) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171294 | da Vinci X Surgical System | Intuitive Surgical, Inc. | 2017 |
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSO... | Intuitive Surgical, Inc. | 2014 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical S... | Intuitive Surgical, Inc. | 2025 |
Trace the full predicate network for K231224
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.