FDA Product Code NBY: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Leading manufacturers include Durastat, LLC.
17
Total
17
Cleared
139d
Avg days
2000
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene Devices (Product Code NBY)
17 devices
About Product Code NBY - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code NBY since 2000, with 17 receiving FDA clearance (average review time: 139 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
NBY devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →