K931156 is an FDA 510(k) clearance for the CONE CATH. This device is classified as a Device, Incontinence, Urosheath Type, Sterile (Class I - General Controls, product code EXJ).
Submitted by Sierra Laboratories, Inc. (Tucson, US). The FDA issued a Cleared decision on July 1, 1993, 114 days after receiving the submission on March 9, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K931156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1993 |
| Decision Date | July 01, 1993 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EXJ — Device, Incontinence, Urosheath Type, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |