Cleared Traditional

TrachCuff Cuff Controller

K220854 · Aw Technologies Aps · Anesthesiology
Apr 2023
Decision
387d
Days
Class 2
Risk

About This 510(k) Submission

K220854 is an FDA 510(k) clearance for the TrachCuff Cuff Controller, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Aw Technologies Aps (Norresundby, DK). The FDA issued a Cleared decision on April 14, 2023, 387 days after receiving the submission on March 23, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K220854 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2022
Decision Date April 14, 2023
Days to Decision 387 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750