FZE · Class II · 21 CFR 878.3680

FDA Product Code FZE: Prosthesis, Nose, Internal

Leading manufacturers include Cmf Medicon Surgical, Inc..

42
Total
42
Cleared
83d
Avg days
1978
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 223d recently vs 80d historically

FDA 510(k) Cleared Prosthesis, Nose, Internal Devices (Product Code FZE)

42 devices
1–24 of 42
Cleared Dec 12, 2024
Medicon Epiplating System
K241253
Cmf Medicon Surgical, Inc.
General & Plastic Surgery · 223d

About Product Code FZE - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code FZE since 1978, with 42 receiving FDA clearance (average review time: 83 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.

FDA Review Time

Recent submissions under FZE have taken an average of 223 days to reach a decision - up from 80 days historically. Manufacturers should account for longer review timelines in current project planning.

FZE devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →