FDA 510(k) Applications for Medical Device Product Code "EXD"
(Irrigator, Ostomy)

FDA 510(k) Number Applicant Device Name Decision Date
K840268 COLOPLAST A/S IRRIGATION SYSTEM 04/05/1984
K121833 COLOPLAST A/S OSTOMY IRRIGATION SET 07/16/2012
K832299 CONVATEC, A DIVISION OF E.R. SQUIBB & SONS VISI-FLOW IRRIGATOR 08/26/1983
K914692 COOK UROLOGICAL, INC. URINARY DIVERSION EVACUATING CATHETER 07/02/1992
K811160 E. R. SQUIBB & SONS, INC. SUR-FIT IRRIGATION SLEEVE 06/02/1981
K823274 HOWMEDICA CORP. UNI-TIP COLOSTOMY IRRIGATION CONE 12/07/1982
K871791 I.B. BLOXOM C/O HOGAN & HARTSON BLOXOM IRRIGATOR 05/20/1987
K904586 PALEX INTL. SA PALEX IRRIGATION SET 12/28/1990
K770251 QUALITONE SUPER X ADJUSTRETTE 02/28/1977
K760810 SHERWOOD MEDICAL INDUSTRIES TUBE, GASTRO-ENTEROSTOMY 02/28/1977
K790750 VABAR CORP. COLOSTOMY DEVICE W/ PRESSURE LID 05/14/1979
K790749 VABAR CORP. COLOSTOMY ENEMA DEVICE 05/16/1979


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