MEG · Class II · 21 CFR 880.5860

FDA Product Code MEG: Syringe, Antistick

Leading manufacturers include Cardinal Health200, LLC, Shina Med Corporation and Medline Industries, LP.

163
Total
163
Cleared
170d
Avg days
1994
Since
Declining activity - 2 submissions in the last 2 years vs 12 in the prior period
Review times increasing: avg 249d recently vs 169d historically

FDA 510(k) Cleared Syringe, Antistick Devices (Product Code MEG)

163 devices
1–24 of 163

About Product Code MEG - Regulatory Context

510(k) Submission Activity

163 total 510(k) submissions under product code MEG since 1994, with 163 receiving FDA clearance (average review time: 170 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 12 in the prior period.

FDA Review Time

Recent submissions under MEG have taken an average of 249 days to reach a decision - up from 169 days historically. Manufacturers should account for longer review timelines in current project planning.

MEG devices are reviewed by the General Hospital panel. Browse all General Hospital devices →