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FDA 510(k)

Aurora Surgiscope System

K-Number: K191861 · 2019-12-06

ApplicantRebound Therapeutics
Decision Date2019-12-06
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Aurora Surgiscope System is the device name listed in this FDA 510(k) record. The listed applicant is Rebound Therapeutics. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K191861. 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 2019-12-06. The listed applicant is Rebound Therapeutics. The 510(k) number is K191861.

When did Aurora Surgiscope System receive FDA 510(k) clearance?

Aurora Surgiscope System received FDA 510(k) clearance on 2019-12-06, under 510(k) number K191861.

Who is the listed applicant for Aurora Surgiscope System?

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 Surgiscope System?

The FDA product code for Aurora Surgiscope System is GWG.

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 SystemK203745AURORA Evacuator +CoagK201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)K201637Aurora Evacuator +CoagK190075Aurora EvacuatorK182211Aurora Surgiscope System

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Related Devices (Code: GWG)

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.

K253602Precision S 4K SinuscopeStryker EndoscopyK253679Hydro Irrigation SystemStryker InstrumentsK243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences CorporationK233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

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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