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FDA 510(k)

StealthConnect Remote Viewing, Planning and Collaboration System

N.º K: K162655 · 2017-04-21

SolicitanteMedtronic Navigation, Inc.
Fecha de decisión2017-04-21
Código de productoHAW
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

StealthConnect Remote Viewing, Planning and Collaboration System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K162655. 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 StealthConnect Remote Viewing, Planning and Collaboration System?

StealthConnect Remote Viewing, Planning and Collaboration System is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K162655.

When did StealthConnect Remote Viewing, Planning and Collaboration System receive FDA 510(k) clearance?

StealthConnect Remote Viewing, Planning and Collaboration System received FDA 510(k) clearance on 2017-04-21, under 510(k) number K162655.

Who is the listed applicant for StealthConnect Remote Viewing, Planning and Collaboration System?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StealthConnect Remote Viewing, Planning and Collaboration System?

The FDA product code for StealthConnect Remote Viewing, Planning and Collaboration System is HAW.

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Otros registros que enlistan a Medtronic Navigation, Inc. como solicitante

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K253379Stealth AXiS Cranial clinical applicationK253395Stealth AXiS™ ENT clinical applicationK253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationK251282StealthStation S8 Spine SoftwareK242464Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

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Dispositivos relacionados (Código: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta 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.

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