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U.S. Department of Health and Human Services

Product Classification
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Device mesh, surgical
Regulation Description Surgical mesh.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeFTM
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Documents
  • Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070852.htm] 
  • Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final
Third Party Review Not Third Party Eligible
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