Identifiers
- 510(k) Number
- K160312 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fraxis Duo is a surgical mesh device designed for use in hernia repair procedures. It is classified under the nomenclature for synthetic absorbable or non-absorbable meshes, intended to provide structural support to weakened abdominal walls or inguinal regions.
This device is supplied sterile, intended for single-use, and is classified under the FDA’s product code GEX (General, Plastic Surgery). It is intended for use in operating room settings and requires proper handling and storage as per manufacturer guidelines. The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of October 28, 2016.
Frequently asked questions
What types of hernia repair procedures is the Fraxis Duo designed for, and how does it provide support to the abdominal wall or inguinal region?
The Fraxis Duo is specifically designed for hernia repair procedures involving weakened abdominal walls or inguinal regions. It functions as a synthetic mesh, offering structural reinforcement to help close and stabilize the defect area, reducing the risk of recurrence. Its absorbable or non-absorbable material (as classified under FDA nomenclature) provides long-term support to the repaired tissue.
Is the Fraxis Duo intended for reuse in multiple surgical procedures, or is it meant to be used only once?
The Fraxis Duo is explicitly supplied as a single-use device. This designation ensures patient safety by preventing contamination or degradation from repeated sterilization or reuse, aligning with standard surgical mesh practices.
How should the Fraxis Duo be stored, and what precautions should be taken to maintain its sterility before use?
The Fraxis Duo is supplied sterile, so it must be stored according to the manufacturer’s guidelines to preserve sterility. This typically involves keeping it in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling—such as avoiding contamination or physical damage—is critical before opening for surgical use.
What regulatory pathway was followed for the FDA clearance of the Fraxis Duo, and what does this mean for its use in the U.S.?
The Fraxis Duo received FDA clearance through the Traditional 510(k) pathway, which demonstrates it is *substantially equivalent* to a legally marketed predicate device. This means it meets FDA standards for safety and effectiveness for its intended use in hernia repair, allowing it to be legally marketed and used in the U.S. under the General, Plastic Surgery product code (GEX).
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160312 | Class II | Active |
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Manufacturer
- Manufacturer
- Ilooda.co., Ltd
- FDA Applicant
- Ilooda Co,., Ltd.
Sources (1)
- FDA 510(k) K160312 24 fields · synced Sep 19, 2026