Company ยท US
Sierra Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1997. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 5 |
| BYN | Chair, Posture, For Cardiac And Pulmonary Treatment | 1 |
| EFD | Amalgamator, Dental, Ac-Powered | 1 |
| EYT | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile | 1 |
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | 1 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 |
| KBC | Saw, Nasal | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 22, 1997 | K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | EXJ |
| Jul 15, 1996 | K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | EXJ |
| Jul 15, 1996 | K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | EXJ |
| Apr 19, 1994 | K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | EXJ |
| Jan 7, 1994 | K934052 | ALPINE REUSABLE LEG BAGS Sierra Laboratories, Inc. | FAQ |
| Jul 1, 1993 | K931156 | CONE CATH Sierra Laboratories, Inc. | EXJ |
| Mar 26, 1990 | K901000 | URO TEX URINALS Sierra Laboratories, Inc. | EYZ |
| Aug 2, 1988 | K883057 | COMFORT CATH MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | EYT |
| Feb 11, 1988 | K873039 | MODEL 820 TOP=TRAK Sierra Laboratories, Inc. | BYN |
| Oct 14, 1983 | K832450 | URO-TEX MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | KNX |
| Jul 27, 1981 | K811887 | SKIN STAPLE EXTRACTOR Sierra Laboratories, Inc. | KBC |
| Sep 19, 1979 | K791410 | AMALGAMATOR MODEL SDC-- Sierra Laboratories, Inc. | EFD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||