Class Class II
Prevena Plus 125 Therapy Unit (K223263)
Description
Prevena Plus 125 Therapy Unit by 3M, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223263
Clearance Date2023-02-13
Clearance TypeTraditional
Product CodeQFC
Regulation Number878.4783
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223263
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. Prevena Plus 125 Therapy Unit (K223263) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo I... | Kci USA, Inc. | 2018 |
| K173447 | V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Start... | Kci USA, Inc. | 2018 |
Trace the full predicate network for K223263
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.