Class Class II
AEON Endoscopic Stapler (K222210)
Description
AEON Endoscopic Stapler by Lexington Medical, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222210
Clearance Date2023-04-21
Clearance TypeTraditional
Product CodeGDW
Regulation Number878.4750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222210
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. AEON Endoscopic Stapler (K222210) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201882 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2020 |
| K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Line... | Ethicon Endo-Surgery, LLC | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251482 | AEON™ Endoscopic Powered Stapler | Lexington Medical, Inc. | 2025 |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endos... | Lexington Medical, Inc. | 2024 |
Trace the full predicate network for K222210
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.