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
206 devices
121–144 of 206
Cleared Dec 28, 1982
FEMALE EXTERNAL URINARY APPLIANCE
K823450
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 41d
Cleared Sep 24, 1982
ADHESIVE SPRAY #4050-4060
K822307
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 52d
Cleared Aug 30, 1982
STERILE FOLEY CATHETERIZATION KITS
K821979
Medical Devices, Inc.
Gastroenterology & Urology · 55d
Cleared Aug 25, 1982
STERILE URETHRAL CATHETERIZATION SET
K821978
Medical Devices, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 10, 1982
ASSURE-MALE EXTERNAL INCONTINCE CATHETER
K821848
Medical Design & Manufacturing Corp.
Gastroenterology & Urology · 49d
Cleared Jul 30, 1982
UROGARD
K821829
Buckman Consultants
Gastroenterology & Urology · 38d
Cleared Jul 22, 1982
U-100 BAG
K821853
Medical Technologies of Georgia
Gastroenterology & Urology · 29d
Cleared Jul 22, 1982
U-200 BAG
K821854
Medical Technologies of Georgia
Gastroenterology & Urology · 29d
Cleared May 24, 1982
DISPOSABLE URINARY LEGBAG W/STRAP
K821168
Medical Marketing Group
Gastroenterology & Urology · 27d
Cleared May 10, 1982
EXTERNAL URINARY MALE INCONTINENCE DEV
K821161
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
URINARY COLLECTION CONTAINER/LEG BAG
K821171
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
EXTERNAL FEMALE URINARY INCONTINENCE
K821172
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 01, 1982
MALE EXTERNAL CATHETER
K820565
Urocare Products, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 12, 1982
CURITY BEDSIDE DRAINAGE BAG
K813621
The Kendal Co.
Gastroenterology & Urology · 45d
Cleared Feb 10, 1982
HOLLISTER FEMALE URINARY COLLECT SYS
K820234
Hollister, Inc.
Gastroenterology & Urology · 13d
Cleared Jan 29, 1982
URINARY DRAINAGE BAG
K820136
Megaplast, Inc.
Gastroenterology & Urology · 11d
Cleared Jan 12, 1982
URIFIX
K813537
Isramed, Inc.
Gastroenterology & Urology · 25d
Cleared Jan 07, 1982
ARGYLE PEDIATRIC URINE COLLECTOR
K813479
Sherwood Medical Co.
Gastroenterology & Urology · 37d
Cleared Nov 02, 1981
FEMEX
K812907
Promac
Gastroenterology & Urology · 14d
Cleared Sep 23, 1981
SKIN ADHESIVE-50XX
K812249
Manfred Sauer Corp.
Gastroenterology & Urology · 43d
Cleared Aug 31, 1981
CONVEEN URISHEATH & CONVEEN URILINER
K812294
Telcam Medical Devices, Inc.
Gastroenterology & Urology · 17d
Cleared Aug 20, 1981
CONDOM-52.XX
K812250
Manfred Sauer Corp.
Gastroenterology & Urology · 9d
Cleared Aug 20, 1981
DISPOSABLE URINE GAB-70.XX
K812251
Manfred Sauer Corp.
Gastroenterology & Urology · 9d
Cleared Aug 20, 1981
LATEX LEG BAG-57.XX
K812252
Manfred Sauer Corp.
Gastroenterology & Urology · 9d