Identifiers
- 510(k) Number
- K213198 FDA 510(k)
- FDA Product Code
- POD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4454 FDA 510(k)
- Regulation Number
- 878.4454 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ax-Surgi Surgical Hemostat is a temporary, internal use hemostatic device. It is classified as a Class II medical device under regulation number 878.4454 and product code POD.
The device received FDA 510(k) clearance (K213198) through a traditional submission process. It is supplied non-sterile and intended for single use. Storage and handling should follow manufacturer guidelines. No MRI safety information is provided in the data.
Frequently asked questions
What is the Ax-Surgi Surgical Hemostat used for?
The Ax-Surgi Surgical Hemostat is a temporary, internal use hemostatic device designed to control bleeding during surgical procedures. It is intended for internal application within the body to achieve hemostasis temporarily, as indicated by its classification under regulation number 878.4454 for temporary internal use hemostatic devices.
Is the Ax-Surgi Surgical Hemostat sterile or non-sterile, and is it reusable?
The Ax-Surgi Surgical Hemostat is supplied non-sterile and is intended for single use only. This means it must not be reused after initial application, and users should follow the manufacturer’s guidelines for handling and storage to maintain device integrity prior to use.
What regulatory pathway was used for the Ax-Surgi Surgical Hemostat, and what is its classification?
The Ax-Surgi Surgical Hemostat received FDA 510(k) clearance through a traditional submission process under clearance type 'Traditional'. It is classified as a Class II medical device under regulation number 878.4454 and product code POD, with device name 'Temporary, Internal Use Hemostatic'.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - Ax-Surgi, Advamedica | Bleeding Control | Vascular Accesses & Trauma, Advamedica Inc announces FDA clearance for Ax-Surgi Surgical Hemostat
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213198 | Class II | Active |
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Manufacturer
- Manufacturer
- Advamedica, Inc.
Sources (1)
- FDA 510(k) K213198 24 fields · synced Sep 22, 2026