FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIBAG, URINE BAG SYSTEM #1109,& 1301-12
K Number: K802012
·
Decision Sep 9, 1980
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
31
Review Days
20
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TRIBAG, URINE BAG SYSTEM #1109,& 1301-12
- K Number
- K802012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Pollak (Intl.), Ltd.
- Date Received
- August 20, 1980
- Decision Date
- September 9, 1980
- 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
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BESECURE EXTERNAL URINARY COLLECTION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMSINO URINARY LEG BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WELCON HUE-VU URINARY DRAINAGE BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Pollak (Intl.), Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K000227 | UMBICUT | Apr 27, 2000 | Substantially Equivalent |
| K810049 | PEDICAT* | Apr 21, 1981 | Substantially Equivalent |
| K810050 | VECAFIX* | Mar 26, 1981 | Substantially Equivalent |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | Oct 31, 1980 | Substantially Equivalent |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | Oct 31, 1980 | Substantially Equivalent |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | Oct 10, 1980 | Substantially Equivalent |
| K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | Sep 26, 1980 | Substantially Equivalent |
| K801991 | PLASTIC FORCEPS CAT.#1001-1010 | Sep 16, 1980 | Substantially Equivalent |
| K801996 | GUAZE BANDAGES CAT.#101-169 | Sep 16, 1980 | Substantially Equivalent |
| K802021 | PEDIBAND CAT.#195-197 | Sep 16, 1980 | Substantially Equivalent |