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EXD — Irrigator, Ostomy Class II

FDA Device Classification

Classification Details

Product Code
EXD
Device Class
Class II
Regulation Number
876.5895
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K121833coloplastOSTOMY IRRIGATION SETJuly 16, 2012
K914692cook urologicalURINARY DIVERSION EVACUATING CATHETERJuly 2, 1992
K904586palex intlPALEX IRRIGATION SETDecember 28, 1990
K871791i.b. bloxom c/o hogan and hartsonBLOXOM IRRIGATORMay 20, 1987
K840268coloplastIRRIGATION SYSTEMApril 5, 1984
K832299convatec, a division of e.r. squibb and sonsVISI-FLOW IRRIGATORAugust 26, 1983
K823274howmedicaUNI-TIP COLOSTOMY IRRIGATION CONEDecember 7, 1982
K811160e. r. squibb and sonsSUR-FIT IRRIGATION SLEEVEJune 2, 1981
K790749vabarCOLOSTOMY ENEMA DEVICEMay 16, 1979
K790750vabarCOLOSTOMY DEVICE W/ PRESSURE LIDMay 14, 1979
K770251qualitoneSUPER X ADJUSTRETTEFebruary 28, 1977
K760810sherwood medical industriesTUBE, GASTRO-ENTEROSTOMYFebruary 28, 1977