Clearance Summary
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) received FDA 510(k) clearance under submission number K251499, sponsored by William Cook Europe Aps. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2025-06-11.
- Submission: K251499
- Applicant / Sponsor: William Cook Europe Aps
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5730
- Decision date: 2025-06-11
Classification & Regulation
This clearance is catalogued under FDA product code BTR and 21 CFR 868.5730, within the Anesthesiology review panel as a Class II device.