Class Class II
SurBlate Ablation System (K223272)
Description
SurBlate Ablation System by Mima-Pro Scientific, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223272
Clearance Date2023-02-28
Clearance TypeTraditional
Product CodeNEY
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223272
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. SurBlate Ablation System (K223272) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K083157 | HS AMICA | H.S Hospital Service S.P.A | 2009 |
Trace the full predicate network for K223272
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.