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

FDA Device Classification

FDA product code EYZ covers "System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile", a Class I medical device regulated under 21 CFR 876.5250. Submissions are reviewed by the Gastroenterology, Urology panel. At least 14 recent 510(k) clearances have been granted under this product code.

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
K891178tecnol new jersey wound careTECNOL SECURE-ALL TUBE HOLDERMay 23, 1989
K890465cypress medical productsCLOSED SYSTEM URINARY DRAINAGE BAGMay 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

FDA data resources