Class Class II
Anovo Surgical System (6Ne) (K250591)
Description
Anovo Surgical System (6Ne) by Momentis Surgical , Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250591
Clearance Date2025-06-06
Clearance TypeTraditional
Product CodeQNM
Regulation Number878.4961
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250591
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. Anovo Surgical System (6Ne) (K250591) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242157 | Anovo Surgical System (Model 6Ne) | Momentis Surgical , Ltd. | 2024 |
| K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo ... | Aktormed GmbH | 2024 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Cur... | Momentis Surgical , Ltd. | 2025 |
Trace the full predicate network for K250591
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.