Class Class II
Genadyne DUO NPWT (K233614)
Description
Genadyne DUO NPWT by Genadyne Biotechnologies, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233614
Clearance Date2024-12-23
Clearance TypeTraditional
Product CodeOMP
Regulation Number878.4780
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233614
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. Genadyne DUO NPWT (K233614) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K162790 | V.A.C.ULTA Negative Pressure Wound Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | 2026 |
Trace the full predicate network for K233614
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.