Class Class II
8 mm Assist Cannula; 12 mm Assist Cannula (K251490)
Description
8 mm Assist Cannula; 12 mm Assist Cannula by Intuitive Surgical, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251490
Clearance Date2025-07-02
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251490
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. 8 mm Assist Cannula; 12 mm Assist Cannula (K251490) cites 2 predicate devices 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 |
| K142683 | 12 mm Endoscopes and Accessories | Intuitive Surgical, Inc. | 2014 |
Trace the full predicate network for K251490
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.