Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (K243187)
Description
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) by Cork Medical, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243187
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. Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (K243187) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K140022 | NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANI... | Cork Medical Products, LLC | 2014 |
Trace the full predicate network for K243187
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.