FDA 510(k)

Stereotaxic Guiding Surgical Devices, NaoTrac S

Numéro K : K242575 · 2025-05-23

DemandeurBrain Navi Biotechnology Co., Ltd.

Date de décision2025-05-23

Code produitHAW

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Stereotaxic Guiding Surgical Devices, NaoTrac S is the device name listed in this FDA 510(k) record. The listed applicant is Brain Navi Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K242575. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Stereotaxic Guiding Surgical Devices, NaoTrac S?

Stereotaxic Guiding Surgical Devices, NaoTrac S is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Brain Navi Biotechnology Co., Ltd.. The 510(k) number is K242575.

When did Stereotaxic Guiding Surgical Devices, NaoTrac S receive FDA 510(k) clearance?

Stereotaxic Guiding Surgical Devices, NaoTrac S received FDA 510(k) clearance on 2025-05-23, under 510(k) number K242575.

Who is the listed applicant for Stereotaxic Guiding Surgical Devices, NaoTrac S?

The FDA 510(k) record lists Brain Navi Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stereotaxic Guiding Surgical Devices, NaoTrac S?

The FDA product code for Stereotaxic Guiding Surgical Devices, NaoTrac S is HAW.

Essais cliniques associés

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Source officielle

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