FDA 510(k)

Ax-Surgi Surgical Hemostat

K-Number: K213198 · 2023-01-05

Decision Date2023-01-05

Product CodePOD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Ax-Surgi Surgical Hemostat is a medical device manufactured by Advamedica, Inc.. It received FDA 510(k) clearance on 2023-01-05 under approval number K213198. The device is classified under product code POD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ax-Surgi Surgical Hemostat?

Ax-Surgi Surgical Hemostat is a medical device that received FDA 510(k) clearance on 2023-01-05. It is manufactured by Advamedica, Inc.. The 510(k) number is K213198.

When was Ax-Surgi Surgical Hemostat approved by the FDA?

Ax-Surgi Surgical Hemostat received FDA 510(k) clearance on 2023-01-05, under approval number K213198.

What company makes Ax-Surgi Surgical Hemostat?

Ax-Surgi Surgical Hemostat is manufactured by Advamedica, Inc..

What is the FDA product code for Ax-Surgi Surgical Hemostat?

The FDA product code for Ax-Surgi Surgical Hemostat is POD.

Related PubMed Literature

PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025)

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Related Devices (Code: POD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.