K261499
- 510(k) number
- K261499
- Device name
- TrachFlush
- Applicant
- Aw Technologies Aps DK
- Product code
- BSK — Cuff, Tracheal Tube, Inflatable
- Decision date
- 2026-08-13
- Date received
- 2026-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261499.pdf
Official FDA record: K261499
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.