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FDA 510(k)

Aurora Surgiscope System

K-Number: K232618 · 2023-10-27

Decision Date2023-10-27
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Aurora Surgiscope System is a medical device manufactured by Rebound Therapeutics Corporation. It received FDA 510(k) clearance on 2023-10-27 under approval number K232618. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aurora Surgiscope System?

Aurora Surgiscope System is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Rebound Therapeutics Corporation. The 510(k) number is K232618.

When was Aurora Surgiscope System approved by the FDA?

Aurora Surgiscope System received FDA 510(k) clearance on 2023-10-27, under approval number K232618.

What company makes Aurora Surgiscope System?

Aurora Surgiscope System is manufactured by Rebound Therapeutics Corporation.

What is the FDA product code for Aurora Surgiscope System?

The FDA product code for Aurora Surgiscope System is GWG.

Other Devices by Rebound Therapeutics Corporation

Related Devices (Code: GWG)

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.