510(k) K253984 · SFE Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
Instrument Exit Point on Touch Surgery Aide
| Applicant | Covidien, LLC, Mansfield MA, US |
| Decision | Substantially Equivalent, Jun 4, 2026 |
| Received | Dec 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253984
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.