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FDA 510(k)

AURORA Evacuator +Coag

K-Number: K203745 · 2021-12-02

ApplicantRebound Therapeutics
Decision Date2021-12-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AURORA Evacuator +Coag is a medical device manufactured by Rebound Therapeutics. It received FDA 510(k) clearance on 2021-12-02 under approval number K203745. 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 +Coag?

AURORA Evacuator +Coag is a medical device that received FDA 510(k) clearance on 2021-12-02. It is manufactured by Rebound Therapeutics. The 510(k) number is K203745.

When was AURORA Evacuator +Coag approved by the FDA?

AURORA Evacuator +Coag received FDA 510(k) clearance on 2021-12-02, under approval number K203745.

What company makes AURORA Evacuator +Coag?

AURORA Evacuator +Coag is manufactured by Rebound Therapeutics.

What is the FDA product code for AURORA Evacuator +Coag?

The FDA product code for AURORA Evacuator +Coag is GEI.

Other Devices by Rebound Therapeutics

K180372Aurora Evacuator K191861Aurora Surgiscope System K190075Aurora Evacuator K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) K201637Aurora Evacuator +Coag

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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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