K091516 is an FDA 510(k) clearance for the WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Well Lead Medical Co., Ltd. (Appollo Beach, US). The FDA issued a Cleared decision on October 16, 2009, 147 days after receiving the submission on May 22, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K091516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2009 |
| Decision Date | October 16, 2009 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZL - Catheter, Retention Type, Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |