FDA Product Code SIW:
Leading manufacturers include Vitestro.
1
Total
0
Cleared
327d
Avg days
2026
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared SIW Devices (Product Code SIW)
1 devices
About Product Code SIW - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SIW since 2026, with 0 receiving FDA clearance (average review time: 327 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.