KNX · Class II · 21 CFR 876.5250

FDA Product Code KNX: Collector, Urine, (and Accessories) For Indwelling Catheter

Leading manufacturers include Conphar, Inc., The Kendal Co. and Coloplast A/S.

206
Total
206
Cleared
60d
Avg days
1976
Since

FDA 510(k) Cleared Collector, Urine, (and Accessories) For Indwelling Catheter Devices (Product Code KNX)

206 devices
1–24 of 206
Cleared Dec 11, 1997
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
K972887
Medline Industries, Inc.
Gastroenterology & Urology · 128d
Cleared Oct 04, 1996
URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
K962652
Customed, Inc.
Gastroenterology & Urology · 88d
Cleared Aug 15, 1995
PROSYS LEG BAG
K952208
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 97d
Cleared Nov 16, 1994
NEEDLELESS URINE SAMPLING PORT
K944236
Kendall Healthcare Products Co. Div.Of Tyco Health
Gastroenterology & Urology · 76d
Cleared Sep 16, 1994
BARD URINE COLLECTION PRODUCTS MODIFICATION
K940206
C.R. Bard, Inc.
Gastroenterology & Urology · 245d
Cleared Jun 14, 1993
KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER
K931459
Kendall Healthcare Products Co. Div.Of Tyco Health
Gastroenterology & Urology · 83d
Cleared May 21, 1993
HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
K926570
Hollister, Inc.
Gastroenterology & Urology · 141d
Cleared May 02, 1990
URINE COLLECTOR LEG BAG
K896688
Medline Industries, Inc.
Gastroenterology & Urology · 155d
Cleared Jun 23, 1989
KENDALL KENGUARD URINARY LEG BAGS
K892437
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared May 05, 1989
KENDALL CURITY URINARY DRAINAGE BAGS
K892433
The Kendal Co.
Gastroenterology & Urology · 25d
Cleared Aug 11, 1988
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP
K881678
Hollister, Inc.
Gastroenterology & Urology · 114d
Cleared Jun 10, 1987
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
K871610
Coloplast A/S
Gastroenterology & Urology · 47d
Cleared Jun 10, 1987
CONVEEN(R) LEG-BAG (600 ML)
K871643
Coloplast A/S
Gastroenterology & Urology · 44d
Cleared Apr 01, 1987
NORTA (TM) UROBAG
K870504
Beiersdorf, Inc.
Gastroenterology & Urology · 56d
Cleared Aug 19, 1986
HOLLISTER FEMALE URINARY COLLECTION POUCH
K862934
Hollister, Inc.
Gastroenterology & Urology · 15d
Cleared Apr 29, 1986
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362
Travenol Laboratories, S.A.
Gastroenterology & Urology · 89d
Cleared Dec 13, 1985
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580
Coloplast A/S
Gastroenterology & Urology · 28d
Cleared Aug 27, 1985
H-H SEXTON SCUP URINE MGMT. SYS
K853458
Holter-Hausner Intl.
Gastroenterology & Urology · 11d
Cleared Aug 07, 1985
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
K852085
The Kendal Co.
Gastroenterology & Urology · 86d
Cleared Jul 24, 1985
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810
C.R. Bard, Inc.
Gastroenterology & Urology · 225d
Cleared Jan 08, 1985
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM
K844684
Coloplast A/S
Gastroenterology & Urology · 39d
Cleared Dec 17, 1984
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
K844280
Travenol Laboratories, S.A.
Gastroenterology & Urology · 42d
Cleared Aug 08, 1984
SUR-FIT NIGHT DRAINAGE CONTAINER SET
K842395
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 50d
Cleared Aug 08, 1984
ACCUSEAL LEG BAGS & EXTENSION TUBES
K842396
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 50d

About Product Code KNX - Regulatory Context