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FDA 510(k)

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

K-Number: K201840 · 2020-11-04

ApplicantRebound Therapeutics
Decision Date2020-11-04
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is a medical device manufactured by Rebound Therapeutics. It received FDA 510(k) clearance on 2020-11-04 under approval number K201840. 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 (Surgiscope), Aurora Surgiscope System (Image Control Box)?

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is a medical device that received FDA 510(k) clearance on 2020-11-04. It is manufactured by Rebound Therapeutics. The 510(k) number is K201840.

When was Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) approved by the FDA?

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) received FDA 510(k) clearance on 2020-11-04, under approval number K201840.

What company makes Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is manufactured by Rebound Therapeutics.

What is the FDA product code for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

The FDA product code for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is GWG.

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Related PubMed Literature

PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Rebound Therapeutics

K180372Aurora Evacuator K191861Aurora Surgiscope System K190075Aurora Evacuator K201637Aurora Evacuator +Coag K203745AURORA Evacuator +Coag

Related Devices (Code: GWG)

K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. K152699Apollo SystemPenumbra, Inc. K170667QEVO System with KINEVO 900Carl Zeiss Meditec, AG K171332Artemis Neuro Evacuation DevicePenumbra, Inc. K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc. K162880TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc.

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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