Class Class U
Corplex P/ Theracor P/ Allacor P (K242828)
Description
Corplex P/ Theracor P/ Allacor P by Stimlabs, LLC, an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK242828
Clearance Date2024-10-18
Clearance TypeSpecial
Product CodeKGN
FDA Database
View on FDA DatabasePredicate lineage for K242828
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. Corplex P/ Theracor P/ Allacor P (K242828) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231325 | Corplex P / Theracor P / Allacor P | Stimlabs, LLC | 2024 |
Trace the full predicate network for K242828
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.