Endoxane Tracheal Prosthesis
FDA 510(k)Class II (US FDA 510(k))
by Novatech Sa
Identifiers
- 510(k) Number
- K971509 FDA 510(k)
- FDA Product Code
- NWA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3720 FDA 510(k)
- Regulation Number
- 878.3720 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- ST FDA 510(k)
The Endoxane Tracheal Prosthesis is a preformed, molded tracheal prosthesis designed for surgical implantation. Classified as a Class II device under 21 CFR 878.3720, it is intended for use in reconstructive or replacement procedures within the trachea, typically in plastic surgery applications.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K971509) with a Product Code of NWA, subject to tracking requirements. No additional MRI safety or size specifications are noted in the regulatory data.
Frequently asked questions
What types of surgical procedures is the Endoxane Tracheal Prosthesis intended for?
The Endoxane Tracheal Prosthesis is specifically designed for reconstructive or replacement procedures within the trachea, primarily used in plastic surgery applications. It is intended to be surgically implanted where tracheal tissue needs to be restored or substituted.
Is the Endoxane Tracheal Prosthesis reusable or single-use, and how is it supplied?
The Endoxane Tracheal Prosthesis is supplied sterile and intended for single-use only. This ensures patient safety and compliance with medical device standards, as reuse is not recommended or supported by the manufacturer.
What regulatory pathway was followed for FDA clearance of the Endoxane Tracheal Prosthesis?
The Endoxane Tracheal Prosthesis received FDA clearance through a 510(k) submission (K971509), classified as a Class II device under 21 CFR 878.3720. It was determined to be *substantially equivalent* to a predicate device and is subject to tracking requirements, meaning it must be reported to the FDA for patient safety monitoring.
Does the Endoxane Tracheal Prosthesis have any specific size or model variations available?
The provided regulatory data does not specify individual size or model variations for the Endoxane Tracheal Prosthesis. However, as a preformed/molded tracheal prosthesis, it is likely designed to fit standard anatomical dimensions. For precise sizing, consultation with the manufacturer or surgical planning is recommended.
What storage conditions should be followed for the Endoxane Tracheal Prosthesis?
Since the Endoxane Tracheal Prosthesis is supplied sterile, it should be stored according to standard sterile medical device protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer’s packaging instructions (not detailed here) should be followed to maintain sterility until use.
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: ENDOXANE (K971509) — FDA 510 (k) | Innolitics, ENDOXANE 510 (k) K971509 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971509 | Class II | Active |
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Manufacturer
- Manufacturer
- Novatech Sa
Sources (1)
- FDA 510(k) K971509 24 fields · synced Sep 19, 2026