Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (K221629)
Description
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) by Covidien, an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221629
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. Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (K221629) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192330 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2020 |
| K182475 | Signia Circular Adapters (for use with Signia Staplers), Tr... | Covidien | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240881 | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Si... | Covidien (Part of Medtronic) | 2024 |
Trace the full predicate network for K221629
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.