FDA Product Code NWJ: Suture, Recombinant Technology
Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation.
Leading manufacturers include Tepha, Inc..
9
Total
8
Cleared
86d
Avg days
2007
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Suture, Recombinant Technology Devices (Product Code NWJ)
9 devices
About Product Code NWJ - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code NWJ since 2007, with 8 receiving FDA clearance (average review time: 86 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
NWJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →