Class Class II
Endoform Reconstructive Template – PLGA (K250598)
Description
Endoform Reconstructive Template - PLGA by Aroa Biosurgery , Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250598
Clearance Date2025-06-03
Clearance TypeTraditional
Product CodeFTM
Regulation Number878.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250598
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. Endoform Reconstructive Template – PLGA (K250598) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214070 | OviTex PRS (Long Term Resorbable) | Tela Bio | 2023 |
| K153633 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly M... | 2016 |
Trace the full predicate network for K250598
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.