Class Class II
SOMAVAC® 100 Sustained Vacuum System (K231063)
Description
SOMAVAC® 100 Sustained Vacuum System by Somavac Medical Solutions, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231063
Clearance Date2023-05-12
Clearance TypeSpecial
Product CodeBTA
Regulation Number878.4780
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231063
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. SOMAVAC® 100 Sustained Vacuum System (K231063) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222856 | SOMAVAC 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | 2022 |
Trace the full predicate network for K231063
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.