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U.S. Department of Health and Human Services

Product Classification

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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 CodeOMD
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(k)
Regulation Number 878.4011
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • 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 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm233027.htm] 
Third Party Review Not Third Party Eligible
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