Class Class II
Ax-Surgi Surgical Hemostat (K213198)
Description
Ax-Surgi Surgical Hemostat by Advamedica, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213198
Clearance Date2023-01-05
Clearance TypeTraditional
Product CodePOD
Regulation Number878.4454
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213198
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. Ax-Surgi Surgical Hemostat (K213198) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202830 | Axiostat Patch | Advamedica, Inc. | 2021 |
| K200167 | QuikClot Control+ | Z-Medica, LLC | 2020 |
Trace the full predicate network for K213198
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.