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FDA 510(k)

Stealth-Midas MR8 System

K-Number: K183644 · 2019-05-22

ApplicantMedtronic Powered Surgical Solutions
Decision Date2019-05-22
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Medtronic Powered Surgical Solutions. The 510(k) number is K183644.

When was Stealth-Midas MR8 System approved by the FDA?

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

What company makes Stealth-Midas MR8 System?

Stealth-Midas MR8 System is manufactured by Medtronic Powered Surgical Solutions.

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

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

Other Devices by Medtronic Powered Surgical Solutions

K160713Stealth-Midas System 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 K183515MR8 Drill System, Midas Rex MR8 ClearView Tools 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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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