Class Class II
SafeAir combi (SFR-combi-US) (K223932)
Description
SafeAir combi (SFR-combi-US) by Lina Medical Aps, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223932
Clearance Date2023-04-26
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223932
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. SafeAir combi (SFR-combi-US) (K223932) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | 2019 |
| K143161 | Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) | Covidien | 2014 |
Trace the full predicate network for K223932
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.