510(k) K253972 ยท OWN Confocal Optical Imaging
IMAGE1 (TC400US); X-to-4U Adapter (TC040)
| Applicant | Karl Storz SE & CO. KG, Tuttlingen, DE |
| Decision | Substantially Equivalent, Feb 12, 2026 |
| Received | Dec 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253972
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.