510(k) K243025 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Ureteral Access Sheath
| Applicant | Seplou (Zhuhai) Co., Ltd., Zhuhai, CN |
| Decision | Substantially Equivalent, Jan 30, 2025 |
| Received | Sep 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243025
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.