FXY · Class II · 21 CFR 878.4040

FDA Product Code FXY: Hood, Surgical

13
Total
13
Cleared
73d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Hood, Surgical Devices (Product Code FXY)

13 devices
1–13 of 13
No devices found for this product code.

About Product Code FXY - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code FXY since 1976, with 13 receiving FDA clearance (average review time: 73 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.