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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 the device name listed in this FDA 510(k) record. The listed applicant is Rebound Therapeutics. It received FDA 510(k) clearance on 2021-12-02 under 510(k) 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. The listed applicant is Rebound Therapeutics. The 510(k) number is K203745.

When did AURORA Evacuator +Coag receive FDA 510(k) clearance?

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

Who is the listed applicant for AURORA Evacuator +Coag?

The FDA 510(k) record lists Rebound Therapeutics as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Rebound Therapeutics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232618Aurora Surgiscope SystemK201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)K201637Aurora Evacuator +CoagK191861Aurora Surgiscope SystemK190075Aurora EvacuatorK182211Aurora Surgiscope System

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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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