EZK · Class II · 21 CFR 876.5980

FDA Product Code EZK: Catheter, Retention Type

Leading manufacturers include Respiratory Support Products, Inc., E-Z-Em, Inc. and Howmedica Corp..

3
Total
3
Cleared
228d
Avg days
1977
Since

FDA 510(k) Cleared Catheter, Retention Type Devices (Product Code EZK)

3 devices
1–3 of 3
Cleared Nov 16, 1992
E-Z-EM ENTEROCLYSIS CATHETER SET
K911349
E-Z-Em, Inc.
Gastroenterology & Urology · 600d
Cleared Oct 31, 1990
URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
K903816
Respiratory Support Products, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 15, 1977
KARAYA GUM POWDER, OSTOMY
K770408
Howmedica Corp.
Gastroenterology & Urology · 11d

About Product Code EZK - Regulatory Context