Product Classification

• Device: mesh, surgical, polymeric
• Regulation Description: Surgical mesh.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: FTL
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 878.3300
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-185 ASTM F881-94 (Reapproved 2022)
  Standard Specification for Silicone Elastomer Facial Implants
• 8-179 ASTM F754-08 (Reapproved 2015)
  Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

Guidance Documents

• Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff

• Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final

Third Party Review

Not Third Party Eligible