510(k) K253437 ยท BTR Tube, Tracheal (W/Wo Connector)
Spiro-VISTA
| Applicant | Spiro Robotics, Hayward CA, US |
| Decision | Substantially Equivalent, Jun 12, 2026 |
| Received | Oct 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253437
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.