Sierra Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | April 22, 1997 |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | July 15, 1996 |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | July 15, 1996 |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | April 19, 1994 |
| K934052 | ALPINE REUSABLE LEG BAGS | January 7, 1994 |
| K931156 | CONE CATH | July 1, 1993 |
| K901000 | URO TEX URINALS | March 26, 1990 |
| K883057 | COMFORT CATH MALE EXTERNAL CATHETER | August 2, 1988 |
| K873039 | MODEL 820 TOP=TRAK | February 11, 1988 |
| K832450 | URO-TEX MALE EXTERNAL CATHETER | October 14, 1983 |
| K811887 | SKIN STAPLE EXTRACTOR | July 27, 1981 |
| K791410 | AMALGAMATOR MODEL SDC-- | September 19, 1979 |