Product Classification

• Device: cutaneous tissue adhesive with mesh
• Regulation Description: Tissue adhesive with adjunct wound closure device for topical approximation of skin.
• Definition: For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.
• Physical State: 1) A liquid adhesive and 2) A self-adhering initiated mesh athat is packaged within an applicator
• Technical Method: Adhesive to hold closed skin edges of wounds
• Target Area: The device is meant to act topically on the skin
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: OMD
• Premarket Review: Plastic and Reconstructive Surgery Devices (DHT4B); Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 878.4011
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Documents

• Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin - Guidance for Industry and FDA Staff

• Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible