Sierra Laboratories, Inc.
Medical device manufacturer in Tucson, AZ.
12510(k) clearances
0PMA approvals
0recalls
Device types
- EXJ Device, Incontinence, Urosheath Type, Sterile 5
- EFD Amalgamator, Dental, Ac-Powered 1
- KBC Saw, Nasal 1
- KNX Collector, Urine, (And Accessories) For… 1
- BYN Chair, Posture, For Cardiac And Pulmonary… 1
- EYT Sheath, Corrugated Rubber, For… 1
- EYZ System, Urine Drainage, Closed, For… 1
- FAQ Bag, Urine Collection, Leg, For External… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K970966 | Comfort Cath Choice Male External CatheterEXJ · Traditional | 04/22/1997SE |
| K962413 | Comfort Cath Special Self Adhering Male External CatheterEXJ · Traditional | 07/15/1996SE |
| K962384 | Comfort Sheath Reusable Male External CatheterEXJ · Traditional | 07/15/1996SE |
| K934266 | Comfort Cath Self Adhering Male External CatheterEXJ · Traditional | 04/19/1994SE |
| K934052 | Alpine Reusable Leg BagsFAQ · Traditional | 01/07/1994SE |
| K931156 | Cone CathEXJ · Traditional | 07/01/1993SE |
| K901000 | Uro Tex UrinalsEYZ · Traditional | 03/26/1990SE |
| K883057 | Comfort Cath Male External CatheterEYT · Traditional | 08/02/1988SE |
| K873039 | Model 820 Top=TrakBYN · Traditional | 02/11/1988SE |
| K832450 | Uro-Tex Male External CatheterKNX · Traditional | 10/14/1983SE |
| K811887 | Skin Staple ExtractorKBC · Traditional | 07/27/1981SE |
| K791410 | Amalgamator Model Sdc--EFD · Traditional | 09/19/1979SE |