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 the device name listed in this FDA 510(k) record. The listed applicant is Advamedica, Inc.. It received FDA 510(k) clearance on 2023-01-05 under 510(k) 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. The listed applicant is Advamedica, Inc.. The 510(k) number is K213198.

When did Ax-Surgi Surgical Hemostat receive FDA 510(k) clearance?

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

Who is the listed applicant for Ax-Surgi Surgical Hemostat?

The FDA 510(k) record lists Advamedica, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Advamedica, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: POD)

K243553QuikClot Control+ Hemostatic DeviceTeleflex Medical K220971QuikClot Control+ Hemostatic DressingZ-Medica, LLC K200167QuikClot Control+Z-Medica, LLC K183190NuStatBeeken Biomedical, LLC

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.