TrachFlush— 510(k) K261499
Substantially EquivalentAw Technologies Aps
FDA 510(k) clearance K261499 for TrachFlush, Substantially Equivalent on 2026-08-13. Applicant: Aw Technologies Aps. Device class: 2.
Summary
AW Technologies' TrachFlush is filed under product code BSK, inflatable tracheal tube cuffs. The record gives no model numbers or further description.
Class II, 21 CFR 868.5750. Anesthesiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
AW Technologies filed from Norresundby, Denmark. The decision came 99 calendar days after FDA received it (May 6 to August 13, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Aw Technologies Aps
- Product code
- Product code BSK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5750
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norresundby, DK
Recent devices under product code BSK
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