K252537 is an FDA 510(k) clearance for the Rusch SoftSimplastic Foley Catheters, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Teleflex Medical Sdn. Bhd. (Kamunting, MY). The FDA issued a Cleared decision on January 20, 2026, 161 days after receiving the submission on August 12, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K252537 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 2025 |
| Decision Date | January 20, 2026 |
| Days to Decision | 161 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 |