Class Class II
da Vinci Surgical System, IS5000 (K250442)
Description
da Vinci Surgical System, IS5000 by Intuitive Surgical, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250442
Clearance Date2025-07-29
Clearance TypeTraditional
Product CodeNAY
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250442
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 Surgical System, IS5000 (K250442) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator... | Intuitive Surgical, Inc. | 2024 |
Trace the full predicate network for K250442
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.