FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URO-TEX MALE EXTERNAL CATHETER
K Number: K832450
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
12
Review Days
80
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Basic Information
- Device Name
- URO-TEX MALE EXTERNAL CATHETER
- K Number
- K832450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Sierra Laboratories, Inc.
- Date Received
- July 26, 1983
- Decision Date
- October 14, 1983
- 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
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Other Clearances by Sierra Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | Apr 22, 1997 | Substantially Equivalent |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | Jul 15, 1996 | Substantially Equivalent |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | Jul 15, 1996 | Substantially Equivalent |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | Apr 19, 1994 | Substantially Equivalent |
| K934052 | ALPINE REUSABLE LEG BAGS | Jan 7, 1994 | Substantially Equivalent |
| K931156 | CONE CATH | Jul 1, 1993 | Substantially Equivalent |
| K901000 | URO TEX URINALS | Mar 26, 1990 | Substantially Equivalent |
| K883057 | COMFORT CATH MALE EXTERNAL CATHETER | Aug 2, 1988 | Substantially Equivalent |
| K873039 | MODEL 820 TOP=TRAK | Feb 11, 1988 | Substantially Equivalent |
| K811887 | SKIN STAPLE EXTRACTOR | Jul 27, 1981 | Substantially Equivalent |