Irrigator, Ostomy

FDA product code EXD · Class II (moderate risk) · 21 CFR 876.5895 · Gastroenterology, Urology

12510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K121833Ostomy Irrigation SetEXD · Special Coloplast A/S07/16/2012SE
K914692Urinary Diversion Evacuating CatheterEXD · Traditional Cook Urological, Inc.07/02/1992SE
K904586Palex Irrigation SetEXD · Traditional Palex Intl. SA12/28/1990SE
K871791Bloxom IrrigatorEXD · Traditional I.B. Bloxom C/O Hogan & Hartson05/20/1987SE
K840268Irrigation SystemEXD · Traditional Coloplast A/S04/05/1984SE
K832299Visi-Flow IrrigatorEXD · Traditional Convatec, A Division of E.R. Squibb & Sons08/26/1983SE
K823274Uni-Tip Colostomy Irrigation ConeEXD · Traditional Howmedica Corp.12/07/1982SE
K811160Sur-Fit Irrigation SleeveEXD · Traditional E. R. Squibb & Sons, Inc.06/02/1981SE
K790749Colostomy Enema DeviceEXD · Traditional Vabar Corp.05/16/1979SE
K790750Colostomy Device W/ Pressure LidEXD · Traditional Vabar Corp.05/14/1979SE
K770251Super X AdjustretteEXD · Traditional Qualitone02/28/1977SE
K760810Tube, Gastro-EnterostomyEXD · Traditional Sherwood Medical Industries02/28/1977SE