Home / Device Classification / FAQ

FAQ — Bag, Urine Collection, Leg, For External Use, Sterile Class I

FDA Device Classification

Classification Details

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K962604convatec, a division of e.r. squibb and sonsPROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZJuly 18, 1996
K960217custom pack reliabilityCPR URINE BAGMarch 28, 1996
K955609coloplastCONVEEN URINE BAG - STERILEDecember 29, 1995
K953767convatec, a division of e.r. squibb and sonsPROSYS BEDSIDE DRAINAGE BAGDecember 20, 1995
K953783coloplastCONVEEN LEG BAG STRAPSeptember 13, 1995
K951945convatec, a division of e.r. squibb and sonsPROSYS LEG BAGMay 25, 1995
K945204nelmedURINE COLLECTOR & ACCESSORIESNovember 2, 1994
K934052sierra laboratoriesALPINE REUSABLE LEG BAGSJanuary 7, 1994
K931727neotech productsURINARY DRAINAGE BAG CADDYJuly 23, 1993
K926035c.r. bardBARD LEG BAG HOLDERDecember 17, 1992
K924406coloplastCONVEEN(R) LEG BAG(500 ML)October 30, 1992
K903611inman liebeltILC LEG BAG HOLDEROctober 26, 1990
K901219orion life systemsEXTERNAL LEG BAGJune 27, 1990
K896129cypress medical productsURINARY LEG BAGApril 16, 1990
K896728boston and pacific co4 SURE URINARY LEG BAGFebruary 20, 1990
K780190baka manufacturing coCATHETER STRAP & RUINARY BAY HOLDERFebruary 21, 1978
K772402fred sammonsQUADRIPLEGIC URINARY DRAINAGE VALVEJanuary 26, 1978
K780032c.r. bardURINARY LEG BAGJanuary 17, 1978