510(k) K260512 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Disposable Ureteral Access Sheath
| Applicant | Yangzhou Fartley Medical Instrument Technology Co., Ltd., Yangzhou, CN |
| Decision | Substantially Equivalent, Sep 21, 2026 |
| Received | Feb 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260512
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.