K253437
- 510(k) number
- K253437
- Device name
- Spiro-VISTA
- Applicant
- Spiro Robotics CA · US
- Product code
- BTR — Tube, Tracheal (W/Wo Connector)
- Decision date
- 2026-06-12
- Date received
- 2025-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253437.pdf
Official FDA record: K253437
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.