Prineo Skin Closure System
De Novo DEN090005
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN090005 | Date30 Apr 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA Product Code
- OMD
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4011
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- DENG De Novo granted
Overview
AI-generated summary, 20 Sep 2026
The Prineo Skin Closure System is a Cutaneous Tissue Adhesive With Mesh, combining a liquid adhesive and a self-adhering mesh to approximate and secure skin edges. It is designed to provide a non-invasive alternative to traditional sutures or staples for wound closure, offering mechanical support while the adhesive sets. The mesh temporarily stabilizes skin edges, ensuring proper alignment during the adhesive’s curing process. This system is intended for use in general and plastic surgery procedures requiring secure, temporary skin closure.
The system is supplied as a sterile, single-use device and is applied directly to approximated skin edges in a clinical setting. It remains in place for 7 to 14 days during the normal wound healing process. The adhesive is non-cytotoxic and intended for external use only, with no MRI safety restrictions specified. Sizes and formulations are standardized for general surgical applications, and the device holds FDA 510(k) clearance under classification II (OMD product code). Storage follows standard sterile medical device protocols.
Other devices from Closure Medical Corp.
Questions
AI-generated answers, 20 Sep 2026
What types of surgical procedures is the Prineo Skin Closure System approved for use in, and how does it differ from traditional sutures or staples?
The Prineo Skin Closure System is FDA-cleared for use in general and plastic surgery procedures requiring secure, temporary skin closure. Unlike traditional sutures or staples, it combines a liquid adhesive with a self-adhering mesh to approximate and stabilize skin edges without invasive insertion. This provides a non-invasive alternative that offers mechanical support during the adhesive’s curing process, typically remaining in place for 7 to 14 days while the wound heals.
Is the Prineo Skin Closure System reusable, and if not, how should it be stored to maintain sterility?
The Prineo Skin Closure System is designed as a sterile, single-use device. To maintain sterility, it should be stored following standard protocols for sterile medical devices, such as in its original packaging, away from direct sunlight or extreme temperatures, and in a clean, dry environment until use.
How long does the Prineo Skin Closure System remain in place on the skin, and is it safe for patients with specific concerns like MRI scans?
The system remains in place for approximately 7 to 14 days, aligning with the normal wound healing process. The adhesive is non-cytotoxic and intended for external use only, but there are no specific MRI safety restrictions mentioned in the provided data, so its compatibility with MRI should be confirmed with the manufacturer if needed.
Are there different sizes or formulations available for the Prineo Skin Closure System, and how are they standardized?
The Prineo Skin Closure System includes standardized sizes and formulations tailored for general surgical applications. While specific measurements or variations aren’t detailed in the data, the system is designed to be versatile for common wound closures in general and plastic surgery, ensuring compatibility across a range of procedures.