Class Class II
LigaSure™ XP Maryland Jaw Sealer/Divider (K223158)
Description
LigaSure™ XP Maryland Jaw Sealer/Divider by Covidien, LLC, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223158
Clearance Date2023-01-23
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223158
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. LigaSure™ XP Maryland Jaw Sealer/Divider (K223158) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191601 | Valleylab FT10 Electrosurgical Platform | Covidien | 2019 |
| K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano... | Covidien | 2017 |
| K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | Covidien | 2016 |
| K143654 | Valleylab LS10 Generator | Covidien, LLC | 2015 |
| K110268 | FORCETRIAD ELECTROSURGICAL GENERATOR | Covidien Lp, Formerly Know AS Valle... | 2011 |
Trace the full predicate network for K223158
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.