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 a medical device manufactured by Rebound Therapeutics. It received FDA 510(k) clearance on 2019-12-06 under approval 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. It is manufactured by Rebound Therapeutics. The 510(k) number is K191861.
When was Aurora Surgiscope System approved by the FDA?
Aurora Surgiscope System received FDA 510(k) clearance on 2019-12-06, under approval number K191861.
What company makes Aurora Surgiscope System?
Aurora Surgiscope System is manufactured by Rebound Therapeutics.
What is the FDA product code for Aurora Surgiscope System?
The FDA product code for Aurora Surgiscope System is GWG.
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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.