Identifiers
- 510(k) Number
- K070918 FDA 510(k)
- FDA Product Code
- FTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 4DDOME is a polymeric surgical mesh device classified as a Class II medical device under FDA regulation 878.3300. It is substantially equivalent to a predicate device and falls under the medical specialty of general and plastic surgery.
The device is manufactured by Cousin Biotech and received FDA 510(k) clearance under K070918 on August 22, 2007. It is supplied as a sterile, single-use implant intended for surgical repair in general and plastic surgery applications.
Frequently asked questions
What is the 4DDOME used for?
The 4DDOME is a polymeric surgical mesh intended for surgical repair in general and plastic surgery applications, as indicated by its FDA 510(k) clearance and classification under regulation 878.3300 for soft tissue reinforcement.
How is the 4DDOME supplied and is it reusable?
The 4DDOME is supplied as a sterile, single-use implant, meaning it is designed for one-time use during surgery and must not be reprocessed or reused to maintain sterility and structural integrity.
What regulatory pathway was used for the 4DDOME?
The 4DDOME received FDA 510(k) clearance under K070918, demonstrating substantial equivalence to a predicate device, which is the standard regulatory route for Class II medical devices like this polymeric surgical mesh.
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: 4DDome - Semi-Resorbable Parietal Implant | Cousin, Inguinal hernia prosthesis - 4DDome® - Cousin Biotech - femoral, 4DDome - Implant Pariétal Semi-Résorbable | Cousin, Cousin Biotech 4ddome38sr 4ddome ®
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070918 | Class II | Active |
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Manufacturer
- Manufacturer
- Cousin Biotech
Sources (1)
- FDA 510(k) K070918 24 fields · synced Sep 21, 2026