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EYZ — System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile Class I

FDA Device Classification

Classification Details

Product Code
EYZ
Device Class
Class I
Regulation Number
876.5250
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K964219goulter medicalZIP CONDOM CATHETERAugust 11, 1997
K961906spectrum medsystemsUNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10November 19, 1996
K952780p.a.mURINARY GEL DRAINAGE SYSTEMDecember 12, 1995
K951597key medical servicesURINARY DRAINAGE BAGAugust 4, 1995
K942753researched, novel medical devices (rn/md)ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINERNovember 2, 1994
K933126patsy j. trisler, j.dCOMFORTCARE SYSTEMFebruary 25, 1994
K930556ezmt valve coNIGHT URINARY DRAINAGE BEDSIDE BAGMay 14, 1993
K896695medline industriesDYNA-FLO URINARY DRAINAGE BAGMay 2, 1990
K901000sierra laboratoriesURO TEX URINALSMarch 26, 1990
K890465cypress medical productsCLOSED SYSTEM URINARY DRAINAGE BAGMay 23, 1989
K891178tecnol new jersey wound careTECNOL SECURE-ALL TUBE HOLDERMay 23, 1989
K882714lsl industriesURINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450January 31, 1989
K780267latex indCATH TRAY W/OUT CATHETERFebruary 24, 1978
K772113travenol laboratoriesURINARY DRAINAGE BAG 2D9017November 16, 1977