FDA 510(k)

TrachCuff Cuff Controller

K-Number: K220854 · 2023-04-14

Decision Date2023-04-14

Product CodeBSK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TrachCuff Cuff Controller is the device name listed in this FDA 510(k) record. The listed applicant is Aw Technologies Aps. It received FDA 510(k) clearance on 2023-04-14 under 510(k) number K220854. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrachCuff Cuff Controller?

TrachCuff Cuff Controller is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Aw Technologies Aps. The 510(k) number is K220854.

When did TrachCuff Cuff Controller receive FDA 510(k) clearance?

TrachCuff Cuff Controller received FDA 510(k) clearance on 2023-04-14, under 510(k) number K220854.

Who is the listed applicant for TrachCuff Cuff Controller?

The FDA 510(k) record lists Aw Technologies Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrachCuff Cuff Controller?

The FDA product code for TrachCuff Cuff Controller is BSK.

Other records listing Aw Technologies Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261499TrachFlush

Related Devices (Code: BSK)

K261499TrachFlushAw Technologies Aps K243562CuffGuardIdmed K242642CuffTrekShanghai Longmann Tech Co., Ltd.K221477AG100sHospitech Respiration , Ltd.K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC K192611CuffixBiovo Technologies , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.