K251499
- 510(k) number
- K251499
- Device name
- Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
- Applicant
- William Cook Europe Aps DK
- Product code
- BTR — Tube, Tracheal (W/Wo Connector)
- Decision date
- 2025-06-11
- Date received
- 2025-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251499.pdf
Official FDA record: K251499
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.