Class Class II
PuraStat (K242250)
Description
PuraStat by 3-D Matrix Europe SAS, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242250
Clearance Date2024-10-22
Clearance TypeTraditional
Product CodeQAU
Regulation Number878.4456
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242250
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. PuraStat (K242250) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222481 | PuraStat | 3-D Matrix, Inc. | 2023 |
Trace the full predicate network for K242250
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.