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KDH — Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Class II

FDA Device Classification

Classification Details

Product Code
KDH
Device Class
Class II
Regulation Number
876.5980
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K983624giltech plusGILTECH PLUS CONNECTING TUBE SETMarch 18, 1999
K981286armmSUPERFLOW IRRIGATION AND ASPIRATION TUBING SETSJune 19, 1998
K971259b.braun medicalCOMBIPORT FLUID LAVAGE DEVICEOctober 27, 1997
K962850ethoxTUM-E-VACFebruary 21, 1997
K951533ballard medical productsEASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITJuly 5, 1995
K923497orion life systemsFLUSHING IRRIGATION SETMarch 21, 1994
K920619tri-med specialtiesTRI-MED GASTRIC LAVAGE SYSTEMSeptember 4, 1992
K920527tri-med specialtiesTRI-MED QUICK-STEP GASTRIC LAVAGE KITSeptember 4, 1992
K914908autovageQUICVAGE PLUSApril 13, 1992
K914907autovageQUICVAGEJanuary 24, 1992
K911788autovageECONOVAGE RJuly 26, 1991
K911919autovageMINIVAGE(R)July 26, 1991
K911324biomedical dynamicsIRRIGATION/ASPIRATION TUBING SETJune 24, 1991
K902421gainor medical europeSTOMACH, GASTRO-ENTEROSTOMYNovember 20, 1990
K900086baxter healthcareHEMORRHOIDAL LIGATOR WITH SUCTIONMarch 19, 1990
K896573clairson industriesEASI-LAV ADULT GASTRIC LAVAGE KITJanuary 29, 1990
K892334surgidyneLEONARD TUBEMay 31, 1989
K860599ethoxETHOX LAVAGE TUBEMarch 11, 1986
K821496innovative surgical productsDISPOSABLE IRRIGA/ASPIR. SYSTEMJune 22, 1982
K781749axiom medicalTUBING, AXIOM SILICONE PENROSEDecember 4, 1978