K970966 is an FDA 510(k) clearance for the COMFORT CATH CHOICE MALE EXTERNAL CATHETER. 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 April 22, 1997, 36 days after receiving the submission on March 17, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K970966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1997 |
| Decision Date | April 22, 1997 |
| Days to Decision | 36 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 |