Class Class II
Senhance Surgical System (K233866)
Description
Senhance Surgical System by Asensus Surgical, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233866
Clearance Date2024-07-19
Clearance TypeTraditional
Product CodeNAY
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233866
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. Senhance Surgical System (K233866) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223095 | Senhance Surgical System | Asensus Surgical, Inc. | 2023 |
| K171699 | da Vinci Xi Surgical System, da Vinci Si Surgical System, d... | Intuitive Surgical, Inc. | 2017 |
Trace the full predicate network for K233866
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.