Class Class II
iovera° System (K243677)
Description
iovera° System by Pacira Biosciences, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243677
Clearance Date2024-12-26
Clearance TypeSpecial
Product CodeGXH
Regulation Number882.4250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243677
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. iovera° System (K243677) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220656 | iovera System | Pacira Biosciences, Inc. | 2022 |
| K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | 2021 |
Trace the full predicate network for K243677
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.