Class Class II
StitchKit (K221527)
Description
StitchKit by Origami Surgical Inc ., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221527
Clearance Date2023-02-14
Clearance TypeTraditional
Product CodeGAM
Regulation Number878.4493
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221527
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. StitchKit (K221527) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221578 | Hexanium ACIF | Spinevision, S.A.S. | 2022 |
Trace the full predicate network for K221527
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.