FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORTA (TM) UROBAG
K Number: K870504
·
Decision Apr 1, 1987
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
45
Review Days
56
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
- NORTA (TM) UROBAG
- K Number
- K870504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Beiersdorf, Inc.
- Date Received
- February 4, 1987
- Decision Date
- April 1, 1987
- 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 Beiersdorf, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | Dec 18, 2009 | Substantially Equivalent |
| K024057 | CURAD SCAR THERAPY | Jun 18, 2003 | Substantially Equivalent |
| K952526 | CUTINOVA CAVITY | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K943363 | CUTIPLAST STERIL | Mar 15, 1995 | Substantially Equivalent |
| K944581 | CUTINOVA THIN WOUND DRESSING | Dec 2, 1994 | Substantially Equivalent for Some Indications |
| K935630 | NORTA | Oct 7, 1994 | Substantially Equivalent |
| K940378 | COVERLET ADHESIVE DRESSING | Jul 29, 1994 | Substantially Equivalent for Some Indications |
| K925630 | ELASTOPLAST HEAT PLASTER | Feb 25, 1994 | Substantially Equivalent |
| K926399 | CUTIFILM(R) FILM | Nov 15, 1993 | Substantially Equivalent |
| K923404 | LUEKOFLEX SURGICAL TAPE | Sep 9, 1992 | Substantially Equivalent |