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FDA 510(k)

DUTAU-NOVATECH®

K-Number: K242324 · 2025-02-06

ApplicantNovatech SA
Decision Date2025-02-06
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DUTAU-NOVATECH® is the device name listed in this FDA 510(k) record. The listed applicant is Novatech SA. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K242324. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUTAU-NOVATECH®?

DUTAU-NOVATECH® is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Novatech SA. The 510(k) number is K242324.

When did DUTAU-NOVATECH® receive FDA 510(k) clearance?

DUTAU-NOVATECH® received FDA 510(k) clearance on 2025-02-06, under 510(k) number K242324.

Who is the listed applicant for DUTAU-NOVATECH®?

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 DUTAU-NOVATECH®?

The FDA product code for DUTAU-NOVATECH® is EOQ.

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.

K243126TRACHEOBRONXANE™ DUMON®K170030NOVATECH TALCAIRK151832NOVATECH TALCAIR

Related Devices (Code: EOQ)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., 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.

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