FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URI-CATH SYSTEM
K Number: K852490
·
Decision Nov 5, 1985
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
26
Review Days
146
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Basic Information
- Device Name
- URI-CATH SYSTEM
- K Number
- K852490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Gesco Intl., Inc.
- Date Received
- June 12, 1985
- Decision Date
- November 5, 1985
- 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
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4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
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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 Gesco Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | Dec 15, 1995 | Substantially Equivalent |
| K940953 | UMBILI-CATH-S | Aug 2, 1994 | Substantially Equivalent |
| K940870 | UMBILI-CATH | Aug 2, 1994 | Substantially Equivalent |
| K940952 | UMBILI-CATH-S-DL | Jul 29, 1994 | Substantially Equivalent |
| K941672 | URI-CATH CATHETER | May 16, 1994 | Substantially Equivalent |
| K941232 | THORA-CATH | May 11, 1994 | Substantially Equivalent |
| K940871 | UMBILI-CATH-P | Apr 29, 1994 | Substantially Equivalent |
| K931989 | VENTRI-CATH | Jul 21, 1993 | Substantially Equivalent |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | Jun 7, 1993 | Unknown |
| K923591 | PALA-NATE | Mar 16, 1993 | Substantially Equivalent |