# K213198: Ax-Surgi Surgical Hemostat

- Pathway: 510(k) (Traditional)
- Applicant: Advamedica, Inc.
- Decided: Jan 5, 2023 after 463 days
- Product code: POD (Temporary, Internal Use Hemostatic)
- Device class: 2
- Regulation: 21 CFR 878.4454
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN160012 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200167: QuikClot Control+, Z-Medica, LLC (2020) Summary page 4.

## Indications for use
The Ax-Surgi Surgical Hemostat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

Source page: https://510kreport.com/device/K213198
Methodology: https://510kreport.com/methodology