FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAG, DISPOSABLE URINARY LEG
K Number: K760260
·
Decision Oct 20, 1976
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
16
Review Days
92
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Basic Information
- Device Name
- BAG, DISPOSABLE URINARY LEG
- K Number
- K760260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Intermed, Inc.
- Date Received
- July 20, 1976
- Decision Date
- October 20, 1976
- Product Code
- KNX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNX), ordered by most recent decision date.
IBAG
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4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
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MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
FDA 510(k)
FDA Class 2
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BESECURE EXTERNAL URINARY COLLECTION SYSTEM
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FDA Class 2
·Gastroenterology, Urology
AMSINO URINARY LEG BAG
FDA 510(k)
FDA Class 2
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WELCON HUE-VU URINARY DRAINAGE BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Intermed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900857 | NON STERILE PARENTERAL SUPPLY KIT | May 22, 1990 | Unknown |
| K842166 | INTERMED, INS STERILE WATER/SALINE | Feb 12, 1985 | Substantially Equivalent |
| K833126 | DRESSING CHANGE TRAYS | Jan 27, 1984 | Substantially Equivalent |
| K833574 | PERCUTANEOUS SHEATH INTRODUCER TRAYS | Jan 11, 1984 | Substantially Equivalent |
| K833573 | CENTRAL VEIN CATH. TRAY CC-20-1420 | Jan 11, 1984 | Substantially Equivalent |
| K833139 | ACUTE HEMODIALYSIS TRAYS | Dec 22, 1983 | Substantially Equivalent |
| K833059 | SUCTION CATHETER TRAYS | Dec 12, 1983 | Substantially Equivalent |
| K821269 | TRACHEOSTOMY CARE TRAYS | May 27, 1982 | Substantially Equivalent |
| K791427 | CATHETERIZATION TRAYS FOLEY AND URETHRAL | Sep 7, 1979 | Substantially Equivalent |
| K791426 | PERITONEAL PAC | Aug 28, 1979 | Substantially Equivalent |