Medical Device Manufacturer · US , Mchenry , IL

The Healthcare Group Laboratories, Inc. - FDA 510(k) Cleared Devices

29 submissions · 29 cleared · Since 1980
29
Total
29
Cleared
0
Denied
FDA 510(k) Regulatory Record - The Healthcare Group Laboratories, Inc. Gastroenterology & Urology
15 devices
1-15 of 15
Cleared Sep 24, 1982
ADHESIVE SPRAY #4050-4060
K822307 · KNX
Gastroenterology & Urology · 52d
Cleared May 10, 1982
EXTERNAL URINARY MALE INCONTINENCE DEV
K821161 · KNX
Gastroenterology & Urology · 14d
Cleared May 10, 1982
URINARY COLLECTION CONTAINER/LEG BAG
K821171 · KNX
Gastroenterology & Urology · 14d
Cleared May 10, 1982
EXTERNAL FEMALE URINARY INCONTINENCE
K821172 · KNX
Gastroenterology & Urology · 14d
Cleared Oct 31, 1980
FEEDING TUBES IN SILICONE 5,6,8&10 SIZES
K802585 · KNT
Gastroenterology & Urology · 11d
Cleared Oct 21, 1980
URETHRAL CATHETERIZATION TRAYS
K801785 · KOD
Gastroenterology & Urology · 85d
Cleared Oct 21, 1980
URINARY CATHETER CARE TRAYS #3700&3710
K801787 · KOD
Gastroenterology & Urology · 85d
Cleared Sep 30, 1980
URINE COLLECTION CONTAINERS, #3600 &3610
K801786 · KOD
Gastroenterology & Urology · 64d
Cleared Aug 13, 1980
CATHETER IRRIGATION SYRINGES, #3100,3110
K801781 · KQT
Gastroenterology & Urology · 16d
Cleared Aug 13, 1980
GENERAL PURPOSE IRRIGATING/ASPIR SYR.
K801782 · KQT
Gastroenterology & Urology · 16d
Cleared Aug 13, 1980
URINARY CATHETERS #3400,3410 &3420
K801784 · KOD
Gastroenterology & Urology · 16d
Cleared May 30, 1980
TUBE FEEDING CONTAINER 1500 ML DISPOSE.
K800955 · KNT
Gastroenterology & Urology · 37d
Cleared May 14, 1980
LARGE VOLUME ENEMA CONTAINER DISPOSABLE
K800959 · FCE
Gastroenterology & Urology · 21d
Cleared May 14, 1980
1500 ML DISPOSABLE ENEMA CONTAINER(1110)
K800960 · FCE
Gastroenterology & Urology · 21d
Cleared May 14, 1980
ENEMA CONTAINER DISP. FOR EMEMA ADMIN.
K800961 · FCE
Gastroenterology & Urology · 21d
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