K162989 is an FDA 510(k) clearance for the Rusch Simplastic Foley Catheters, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on February 24, 2017, 120 days after receiving the submission on October 27, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K162989 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 27, 2016 |
| Decision Date | February 24, 2017 |
| Days to Decision | 120 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 |