FDA 510(k)

Stereotaxic Guiding Surgical Devices, NaoTrac S

N.º K: K242575 · 2025-05-23

SolicitanteBrain Navi Biotechnology Co., Ltd.

Fecha de decisión2025-05-23

Código de productoHAW

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: HAW)

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB K253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.