510(k) K243011 ยท EZL Catheter, Retention Type, Balloon
Silicone Urethral Catheter (Silicone Urethral Catheter)
| Applicant | Guangdong Ecan Medical Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jun 16, 2025 |
| Received | Sep 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243011
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.