510(k) K243820 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
| Applicant | Dornier Medtech America, Kennesaw GA, US |
| Decision | Substantially Equivalent, Jan 31, 2025 |
| Received | Dec 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243820
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.