Suture, Nonabsorbable, Synthetic, Polyester

Device Code: 5601

Product Code(s): GAS

Device Classification Information

• Device Type ID: 5601
• Device Name: Suture, Nonabsorbable, Synthetic, Polyester
• Regulation Description: Nonabsorbable Poly(ethylene Terephthalate) 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: 878.5000 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GAS
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-417 USP 41-NF36:2018
  <871> Sutures - Needle Attachment

Total Product Life Cycle

• Device Type ID: 5601
• Device: Suture, Nonabsorbable, Synthetic, Polyester
• Product Code: GAS
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Nonabsorbable Poly(ethylene Terephthalate) Surgical Suture.
• CFR Regulation Number: 878.5000 [🔎]

Device Problems
Suture	5
Adverse Event Without Identified Device Or Use Problem	4
Particulates	1
Total Device Problems	10

TPLC Last Update: 2019-04-02 21:09:13