FEX · Class I · 21 CFR 876.5090

FDA Product Code FEX: Instrument, Catheter, Punch

Leading manufacturers include Xomed, Inc. and Hgm Medical Laser Systems, Inc..

2
Total
2
Cleared
52d
Avg days
1977
Since

FDA 510(k) Cleared Instrument, Catheter, Punch Devices (Product Code FEX)

2 devices
1–2 of 2
Cleared Jun 11, 1991
PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1
K911104
Hgm Medical Laser Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 26, 1977
BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.
K771725
Xomed, Inc.
Gastroenterology & Urology · 13d

About Product Code FEX - Regulatory Context