FDA 510(k)

Aurora Evacuator

K-Number: K180372 · 2018-04-09

Decision Date2018-04-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Aurora Evacuator is a medical device manufactured by Rebound Therapeutics. It received FDA 510(k) clearance on 2018-04-09 under approval number K180372. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aurora Evacuator?

Aurora Evacuator is a medical device that received FDA 510(k) clearance on 2018-04-09. It is manufactured by Rebound Therapeutics. The 510(k) number is K180372.

When was Aurora Evacuator approved by the FDA?

Aurora Evacuator received FDA 510(k) clearance on 2018-04-09, under approval number K180372.

What company makes Aurora Evacuator?

Aurora Evacuator is manufactured by Rebound Therapeutics.

What is the FDA product code for Aurora Evacuator?

The FDA product code for Aurora Evacuator is GEI.

Other Devices by Rebound Therapeutics

K191861Aurora Surgiscope System K190075Aurora Evacuator K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) K201637Aurora Evacuator +Coag K203745AURORA Evacuator +Coag

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Official Source

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