K142563 is an FDA 510(k) clearance for the Well Lead PVC Urethral Catheter. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 28, 2014, 47 days after receiving the submission on September 11, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K142563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2014 |
| Decision Date | October 28, 2014 |
| Days to Decision | 47 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 |