Product Classification

• Device: suture, surgical, absorbable, polydioxanone
• Regulation Description: Absorbable polydioxanone surgical suture.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: NEW
• Submission Type: 510(k)
• Regulation Number: 878.4840
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• USP 35-NF 30 <881> Tensile Strength
• USP 35-NF 30 <861> Sutures - Diameter
• USP 35-NF30 <871> Sutures - Needle Attachment
• USP 35-NF 35:2012 Absorbable Surgical Suture

Guidance Document

• Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA

Third Party Review

Not Third Party Eligible