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KNX — Collector, Urine, (And Accessories) For Indwelling Catheter Class II

FDA Device Classification

Classification Details

Product Code
KNX
Device Class
Class II
Regulation Number
876.5250
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K110518future path medicalIBAGJune 24, 2011
K973364maersk medical4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMarch 17, 1998
K972887medline industriesMEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGDecember 11, 1997
K971271urology research intlBESECURE EXTERNAL URINARY COLLECTION SYSTEMAugust 18, 1997
K971929amsino intlAMSINO URINARY LEG BAGAugust 6, 1997
K971764welconWELCON HUE-VU URINARY DRAINAGE BAGJuly 29, 1997
K964690cleveland medical devicesLIBERTY VALVEMarch 21, 1997
K964745amsino intlAMSINO URINARY DRAINAGE BAGMarch 18, 1997
K962652customedURINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)October 4, 1996
K960949bristol-myers squibbPROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167April 19, 1996
K952208convatec, a division of e.r. squibb and sonsPROSYS LEG BAGAugust 15, 1995
K944377regulatory and marketing servicesORION'S URINARY DRAINAGE SETDecember 6, 1994
K944236kendall healthcare products co. div.of tyco healthNEEDLELESS URINE SAMPLING PORTNovember 16, 1994
K940206c.r. bardBARD URINE COLLECTION PRODUCTS MODIFICATIONSeptember 16, 1994
K941447simpla plasticsSIMPLA S4, S5, S7July 18, 1994
K935557puritas health careURINARY DRAINAGE BAGMarch 7, 1994
K931459kendall healthcare products co. div.of tyco healthKENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBERJune 14, 1993
K925067simport plasticsSIMPLA TRIDENT LEG BAG + SIMPLA S6 BAGJune 10, 1993
K926570hollisterHOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878May 21, 1993
K921024neotech productsURO-TOTE LEG BAGSeptember 2, 1992