K050008 is an FDA 510(k) clearance for the MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on June 3, 2005, 151 days after receiving the submission on January 3, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K050008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2005 |
| Decision Date | June 03, 2005 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD — Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |