FAQ · Class I · 21 CFR 876.5250

FDA Product Code FAQ: Bag, Urine Collection, Leg, For External Use, Sterile

Leading manufacturers include Convatec, A Division of E.R. Squibb & Sons, C.R. Bard, Inc. and Coloplast Corp..

18
Total
18
Cleared
65d
Avg days
1978
Since

FDA 510(k) Cleared Bag, Urine Collection, Leg, For External Use, Sterile Devices (Product Code FAQ)

18 devices
1–18 of 18
Cleared Jul 18, 1996
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
K962604
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 16d
Cleared Dec 29, 1995
CONVEEN URINE BAG - STERILE
K955609
Coloplast Corp.
Gastroenterology & Urology · 21d
Cleared Dec 20, 1995
PROSYS BEDSIDE DRAINAGE BAG
K953767
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 131d
Cleared Sep 13, 1995
CONVEEN LEG BAG STRAP
K953783
Coloplast Corp.
Gastroenterology & Urology · 30d
Cleared May 25, 1995
PROSYS LEG BAG
K951945
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 29d
Cleared Dec 17, 1992
BARD LEG BAG HOLDER
K926035
C.R. Bard, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 30, 1992
CONVEEN(R) LEG BAG(500 ML)
K924406
Coloplast A/S
Gastroenterology & Urology · 66d
Cleared Jun 27, 1990
EXTERNAL LEG BAG
K901219
Orion Life Systems, Inc.
Gastroenterology & Urology · 106d
Cleared Apr 16, 1990
URINARY LEG BAG
K896129
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 175d
Cleared Jan 26, 1978
QUADRIPLEGIC URINARY DRAINAGE VALVE
K772402
Fred Sammons, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 17, 1978
URINARY LEG BAG
K780032
C.R. Bard, Inc.
Gastroenterology & Urology · 8d

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