KNX · Class II · 21 CFR 876.5250

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

Leading manufacturers include The Kendal Co., Conphar, Inc. and Concord Laboratories, Inc..

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 Jun 24, 2011
IBAG
K110518
Future Path Medical, LLC
Gastroenterology & Urology · 121d
Cleared Mar 17, 1998
4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
K973364
Maersk Medical A/S
Gastroenterology & Urology · 190d
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 Aug 18, 1997
BESECURE EXTERNAL URINARY COLLECTION SYSTEM
K971271
Urology Research Intl., Inc.
Gastroenterology & Urology · 136d
Cleared Aug 06, 1997
AMSINO URINARY LEG BAG
K971929
Amsino Intl., Inc.
Gastroenterology & Urology · 71d
Cleared Jul 29, 1997
WELCON HUE-VU URINARY DRAINAGE BAG
K971764
Welcon, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 21, 1997
LIBERTY VALVE
K964690
Cleveland Medical Devices, Inc.
Gastroenterology & Urology · 119d
Cleared Mar 18, 1997
AMSINO URINARY DRAINAGE BAG
K964745
Amsino Intl., Inc.
Gastroenterology & Urology · 112d
Cleared Oct 04, 1996
URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
K962652
Customed, Inc.
Gastroenterology & Urology · 88d
Cleared Apr 19, 1996
PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167
K960949
Bristol-Myers Squibb
Gastroenterology & Urology · 39d
Cleared Aug 15, 1995
PROSYS LEG BAG
K952208
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 97d
Cleared Dec 06, 1994
ORION'S URINARY DRAINAGE SET
K944377
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 90d
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 Jul 18, 1994
SIMPLA S4, S5, S7
K941447
Simpla Plastics , Ltd.
Gastroenterology & Urology · 116d
Cleared Mar 07, 1994
URINARY DRAINAGE BAG
K935557
Puritas Health Care, Inc.
Gastroenterology & Urology · 110d
Cleared Jun 14, 1993
KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER
K931459
Kendall Healthcare Products Co. Div.Of Tyco Health
Gastroenterology & Urology · 83d
Cleared Jun 10, 1993
SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG
K925067
Simport Plastics, Ltd.
Gastroenterology & Urology · 248d
Cleared May 21, 1993
HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
K926570
Hollister, Inc.
Gastroenterology & Urology · 141d
Cleared Sep 02, 1992
URO-TOTE LEG BAG
K921024
Neotech Products, Inc.
Gastroenterology & Urology · 183d
Cleared Sep 23, 1991
BODEN WHEELCHAIR DRAINAGE SYSTEM
K913142
Mno Medical Products
Gastroenterology & Urology · 69d
Cleared Sep 04, 1991
STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
K913223
Medical Device Inspection Co., Inc.
Gastroenterology & Urology · 47d
Cleared Jan 25, 1991
ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG
K901320
Ep Medical, Inc.
Gastroenterology & Urology · 310d
Cleared Jul 16, 1990
BAG, URINE
K902417
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 46d

About Product Code KNX - Regulatory Context