Class Class II
Suture-TOOL System (K242835)
Description
Suture-TOOL System by Suturion AB, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242835
Clearance Date2025-01-22
Clearance TypeTraditional
Product CodeNEW
Regulation Number878.4840
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242835
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. Suture-TOOL System (K242835) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018 |
| K150553 | Filbloc | Assut Europe | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250977 | Suture-TOOL System | Suturion AB | 2025 |
Trace the full predicate network for K242835
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.