Class Class II
NeoGen PSR System (K221873)
Description
NeoGen PSR System by Energist Limited, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221873
Clearance Date2023-01-12
Clearance TypeSpecial
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221873
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. NeoGen PSR System (K221873) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222873 | Attain Command + SureValve Delivery System, Attain Select I... | Medtronic | 2022 |
| K132754 | NEOGEN PSR SYSTEM | Energist, Ltd. | 2013 |
| K072394 | PORTRAIT STAND-OFF | Rhytec Incorporated | 2007 |
Trace the full predicate network for K221873
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.