510(k) K250389 ยท KNT Tubes, Gastrointestinal (And Accessories)
XNY Disposable Gastric Calibration Tube
| Applicant | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, Changzhou, CN |
| Decision | Substantially Equivalent, Apr 10, 2025 |
| Received | Feb 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250389
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.