FDA 510(k)

TRACHEOBRONXANE™ DUMON®

K-Number: K243126 · 2024-10-29

Decision Date2024-10-29

Product CodeNWA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TRACHEOBRONXANE™ DUMON® is the device name listed in this FDA 510(k) record. The listed applicant is Novatech SA. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K243126. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEOBRONXANE™ DUMON®?

TRACHEOBRONXANE™ DUMON® is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Novatech SA. The 510(k) number is K243126.

When did TRACHEOBRONXANE™ DUMON® receive FDA 510(k) clearance?

TRACHEOBRONXANE™ DUMON® received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243126.

Who is the listed applicant for TRACHEOBRONXANE™ DUMON®?

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

What is the FDA product code for TRACHEOBRONXANE™ DUMON®?

The FDA product code for TRACHEOBRONXANE™ DUMON® is NWA.

Other records listing Novatech SA 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.

K242324DUTAU-NOVATECH®K170030NOVATECH TALCAIR K151832NOVATECH TALCAIR

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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.