Product Classification

• Device: suture, surgical, nonabsorbable, poly (vinylidene fluoride)
• Regulation Description: Nonabsorbable polypropylene surgical suture.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: MXW
• Submission Type: 510(k)
• Regulation Number: 878.5010
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ASTM F754-08 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

Third Party Review

Not Third Party Eligible