QCW · Class II · 21 CFR 886.4320

FDA Product Code QCW: Corneal Storage Media With Preservatives Including Anti-fungal

Media To Preserve Human Corneas While In Storage.

Leading manufacturers include Al.Chi.Mi.A. S.R.L.

1
Total
0
Cleared
578d
Avg days
2022
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Corneal Storage Media With Preservatives Including Anti-fungal Devices (Product Code QCW)

1 devices
1–1 of 1

About Product Code QCW - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QCW since 2022, with 0 receiving FDA clearance (average review time: 578 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

QCW devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →