K250243
- 510(k) number
- K250243
- Device name
- ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
- Applicant
- Flexicare Medical Limited. GB
- Product code
- BTR — Tube, Tracheal (W/Wo Connector)
- Decision date
- 2025-05-20
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250243.pdf
Official FDA record: K250243
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.