510(k) K250388 ยท HIF Insufflator, Laparoscopic
ENDOFLATOR +
| Applicant | Karl Storz SE & CO. KG, Tuttlingen, DE |
| Decision | Substantially Equivalent, Sep 22, 2025 |
| Received | Feb 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250388
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.