K901000 is an FDA 510(k) clearance for the URO TEX URINALS. This device is classified as a System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (Class I - General Controls, product code EYZ).
Submitted by Sierra Laboratories, Inc. (Tucson, US). The FDA issued a Cleared decision on March 26, 1990, 24 days after receiving the submission on March 2, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K901000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1990 |
| Decision Date | March 26, 1990 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EYZ — System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |