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KNY — Accessories, Catheter, G-U Class II

FDA Device Classification

FDA product code KNY covers "Accessories, Catheter, G-U", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KNY
Device Class
Class II
Regulation Number
876.5130
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K182144promepla samBi-Flex EvoSeptember 7, 2018
K162356solace therapeuticsVesair Cystoscopic SheathMarch 2, 2017
K140441promepla samBI-FLEX URETERAL ACCESS SHEATHJune 17, 2014
K140562leomedWIJAY EZ-VOID EXTERNAL CATHETER VALVEJune 16, 2014
K141252solace therapeuticsGUARDIAN URETHRAL SHEATHJune 9, 2014
K131803solace therapeuticsGUARDIAN URETHRAL SHEATHAugust 20, 2013
K123170olympus surgical technologies americaVARI-PASS VARIABLE LENGTH ACCESS SHEATHFebruary 4, 2013
K120160promepla samROCAMED ROCAUS PLATINUMMay 14, 2012
K112209avail medical productsPREFILLED CATHETER INFLATION SYRINGESeptember 8, 2011
K090121avail medical productsPRE-FILLED CATHETER INFLATION SYRINGEApril 15, 2009
K052298percutaneous systems, incorporatedCYSTOGLIDE INTRODUCER SHEATHDecember 12, 2006
K062240chief medicalCAREVENTOctober 16, 2006
K052952physician technologiesCATHASSISTMay 14, 2006
K052134percutaneous systemsCYSTOGLIDE DILATING INTRODUCER SHEATHSeptember 22, 2005
K051593acmi corporationUROPASS URETERAL ACCESS SHEATH, MODEL 61224September 2, 2005
K042531percutaneous systems, incorporatedUPDATED SLIP UROLOGY INTRODUCER SHEATHFebruary 1, 2005
K042877percutaneous systemsMICROVERTER URETERAL ACCESS SHEATHNovember 16, 2004
K040520percutaneous systemsSLIP UROLOGY INTRODUCER SHEATHMay 20, 2004
K032127hemedex incorporatedHEMEDEX FIXATION DEVICEDecember 30, 2003
K023690world metalsCATHETER CONNECTORFebruary 28, 2003

FDA data resources