K250243 is an FDA 510(k) clearance for the ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U). This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Flexicare Medical Limited. (Rhondda Cynon Taf, GB). The FDA issued a Cleared decision on May 20, 2025, 113 days after receiving the submission on January 27, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K250243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2025 |
| Decision Date | May 20, 2025 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| 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 |