Suture, Surgical, Nonabsorbable, Poly (vinylidene Fluoride)

Device Code: 5755

Product Code(s): MXW

Device Classification Information

• Device Type ID: 5755
• Device Name: Suture, Surgical, Nonabsorbable, Poly (vinylidene Fluoride)
• Regulation Description: Nonabsorbable Polypropylene Surgical Suture.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Surgical Devices (DSD); General Surgery Devices Branch One - Light Based/Laser (GSDB1)
• Submission Type: 510(k)
• CFR Regulation Number: 878.5010 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MXW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-414 USP 41-NF36:2018
  Nonabsorbable Surgical Suture
• 6-415 USP 41-NF36:2018
  <881> Tensile Strength
• 6-416 USP 41-NF36:2018
  <861> Sutures - Diameter
• 6-417 USP 41-NF36:2018
  <871> Sutures - Needle Attachment
• 8-179 ASTM F754-08 (Reapproved 2015)
  Standard Specification For Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, And Rod Shapes Fabricated From Granular Molding Powders

Total Product Life Cycle

• Device Type ID: 5755
• Device: Suture, Surgical, Nonabsorbable, Poly (vinylidene Fluoride)
• Product Code: MXW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Nonabsorbable Polypropylene Surgical Suture.
• CFR Regulation Number: 878.5010 [🔎]

TPLC Last Update: 2019-04-02 21:11:59