Product Classification

• Device: suture, recombinant technology
• Regulation Description: Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
• Definition: Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
• Physical State: Polymer (solid)
• Technical Method: Produced through recombinant DNA technology
• Target Area: General soft tissues in the body.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: NWJ
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 878.4494
• 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

• 6-468 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

Guidance Document

• Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible