K243562
- 510(k) number
- K243562
- Device name
- CuffGuard
- Applicant
- Idmed FR
- Product code
- BSK — Cuff, Tracheal Tube, Inflatable
- Decision date
- 2025-08-12
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K243562.pdf
Official FDA record: K243562
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.