FDA 510(k)

Stealth-Midas MR8 System

N.º K: K183644 · 2019-05-22

SolicitanteMedtronic Powered Surgical Solutions

Fecha de decisión2019-05-22

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Stealth-Midas MR8 System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Powered Surgical Solutions. It received FDA 510(k) clearance on 2019-05-22 under 510(k) number K183644. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Stealth-Midas MR8 System?

Stealth-Midas MR8 System is a medical device that received FDA 510(k) clearance on 2019-05-22. The listed applicant is Medtronic Powered Surgical Solutions. The 510(k) number is K183644.

When did Stealth-Midas MR8 System receive FDA 510(k) clearance?

Stealth-Midas MR8 System received FDA 510(k) clearance on 2019-05-22, under 510(k) number K183644.

Who is the listed applicant for Stealth-Midas MR8 System?

The FDA 510(k) record lists Medtronic Powered Surgical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stealth-Midas MR8 System?

The FDA product code for Stealth-Midas MR8 System is OLO.

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Otros registros que enlistan a Medtronic Powered Surgical Solutions como solicitante

K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm K183515MR8 Drill System, Midas Rex MR8 ClearView Tools K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools K163565MR8 Drill System K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories K160713Stealth-Midas System

Ver todos los 7 dispositivos →

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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.