FDA 510(k) Applications for Medical Device Product Code "KNX"
(Collector, Urine, (And Accessories) For Indwelling Catheter)

FDA 510(k) Number Applicant Device Name Decision Date
K964745 AMSINO INTL., INC. AMSINO URINARY DRAINAGE BAG 03/18/1997
K971929 AMSINO INTL., INC. AMSINO URINARY LEG BAG 08/06/1997
K960949 BRISTOL-MYERS SQUIBB PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 04/19/1996
K964690 CLEVELAND MEDICAL DEVICES, INC. LIBERTY VALVE 03/21/1997
K962652 CUSTOMED, INC. URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) 10/04/1996
K110518 FUTURE PATH MEDICAL, LLC IBAG 06/24/2011
K973364 MAERSK MEDICAL A/S 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG 03/17/1998
K972887 MEDLINE INDUSTRIES, INC. MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG 12/11/1997
K971271 UROLOGY RESEARCH INTL., INC. BESECURE EXTERNAL URINARY COLLECTION SYSTEM 08/18/1997
K971764 WELCON, INC. WELCON HUE-VU URINARY DRAINAGE BAG 07/29/1997


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