K251499 is an FDA 510(k) clearance for the Frova Intubating Introducer (C-CAE-14.0-70-FII). This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on June 11, 2025, 27 days after receiving the submission on May 15, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K251499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2025 |
| Decision Date | June 11, 2025 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTR - Tube, Tracheal (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5730 |