FDA 510(k)

Stealth-Midas System

Número K: K160713 · 2016-05-26

RequerenteMedtronic Powered Surgical Solutions

Data da decisão2016-05-26

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stealth-Midas 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 2016-05-26 under 510(k) number K160713. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Stealth-Midas System?

Stealth-Midas System is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Medtronic Powered Surgical Solutions. The 510(k) number is K160713.

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

Stealth-Midas System received FDA 510(k) clearance on 2016-05-26, under 510(k) number K160713.

Who is the listed applicant for Stealth-Midas 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 System?

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

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Outros registros que listam Medtronic Powered Surgical Solutions como candidato(a)

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 K183644Stealth-Midas MR8 System 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

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Fonte oficial

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