K173340 is an FDA 510(k) clearance for the Yikang Latex Foley Catheter. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Jiangxi Yikang Medical Instrument Group Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on July 13, 2018, 263 days after receiving the submission on October 23, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K173340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2017 |
| Decision Date | July 13, 2018 |
| Days to Decision | 263 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 |