Product Classification

• Device: suture, absorbable, synthetic, polyglycolic acid
• Regulation Description: Absorbable poly(glycolide/l-lactide) surgical suture.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: GAM
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 878.4493
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-467 USP-NF M80200_04_01
  Nonabsorbable Surgical Suture
• 6-468 USP-NF M99670_02_01
  <881> Tensile Strength
• 6-469 USP-NF M99650_02_01
  <861> Sutures - Diameter
• 6-470 USP-NF M99660_03_01
  <871> Sutures - Needle Attachment
• 6-473 USP-NF M80190_04_01
  Absorbable Surgical Suture
• 8-589 ASTM F1925-22
  Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

Guidance Documents

• Guidance for Surgical Suture 510(k)s

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

• Surgical Sutures - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible