FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALPINE REUSABLE LEG BAGS
K Number: K934052
·
Decision Jan 7, 1994
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
17
Applicant Total
12
Review Days
141
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
- ALPINE REUSABLE LEG BAGS
- K Number
- K934052
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sierra Laboratories, Inc.
- Date Received
- August 19, 1993
- Decision Date
- January 7, 1994
- Product Code
- FAQ
- 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 |
|---|---|---|---|
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAQ), ordered by most recent decision date.
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CPR URINE BAG
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CONVEEN URINE BAG - STERILE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PROSYS BEDSIDE DRAINAGE BAG
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CONVEEN LEG BAG STRAP
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PROSYS LEG BAG
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
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 |
| 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 |
| K832450 | URO-TEX MALE EXTERNAL CATHETER | Oct 14, 1983 | Substantially Equivalent |
| K811887 | SKIN STAPLE EXTRACTOR | Jul 27, 1981 | Substantially Equivalent |