TrachCuff Cuff Controller

FDA 510(k) K220854 · Aw Technologies Aps

Substantially Equivalent

510(k) numberK220854

Submission

Device name
TrachCuff Cuff Controller
Applicant
Aw Technologies Aps
Norresundby, DK
Received
March 23, 2022
Decision date
April 14, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BSK – Cuff, Tracheal Tube, Inflatable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5750
Specialty
Anesthesiology
Life-sustaining
Yes

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Questions and answers

When was TrachCuff Cuff Controller cleared by the FDA?

TrachCuff Cuff Controller (K220854) received a 510(k) decision of Substantially Equivalent on April 14, 2023, 387 days after the submission was received.

What is the product code of K220854?

The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.