510(k) K222880 ยท KNT Tubes, Gastrointestinal (And Accessories)
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
| Applicant | Endolumik, Inc., Morgantown WV, US |
| Decision | Substantially Equivalent, Mar 3, 2023 |
| Received | Sep 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222880
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.