Product code EZK— Gastroenterology, Urology

E-Z-EM ENTEROCLYSIS CATHETER SET

Classification name: Catheter, Retention Type
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Total cleared: 3
First cleared: 1977-03-15
Most recent: 1992-11-16

Market context for product code EZK

FDA has cleared 3 devices under product code EZK between 1977 and 1992, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19921 clearance
19901 clearance
19771 clearance

Top applicants under product code EZK

Respiratory Support Products, Inc.1 clearance
Howmedica Corp.1 clearance
E-Z-Em, Inc.1 clearance

Recent clearances under product code EZK

K911349 — E-Z-EM ENTEROCLYSIS CATHETER SETE-Z-Em, Inc.·1992-11-16
K903816 — URINE METER FOLEY TRAY WITH TEMPERATURE SENSORRespiratory Support Products, Inc.·1990-10-31
K770408 — KARAYA GUM POWDER, OSTOMYHowmedica Corp.·1977-03-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.