Submission Details
| 510(k) Number | K240114 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2024 |
| Decision Date | October 16, 2024 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
UltraEzAir? (UEA1A)
Oct 2024
Decision
274d
Days
Class 2
Risk
About This 510(k) Submission
K240114 is an FDA 510(k) clearance for the UltraEzAir? (UEA1A), a Applicator (laryngo-tracheal), Topical Anesthesia (Class II — Special Controls, product code CCT), submitted by Dualams, Inc., Dba Airkor (Dallas, US). The FDA issued a Cleared decision on October 16, 2024, 274 days after receiving the submission on January 16, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5170.
Device Classification
| Product Code | CCT — Applicator (laryngo-tracheal), Topical Anesthesia |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5170 |
Manufacturer
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