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FDA 510(k), K201840, Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
FDA 510(k), K201840, Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
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510(K) Number: K201840
Device Name: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
Manufacturer: Rebound Therapeutics
Device Classification Name: Endoscope, Neurological
Regulation Number: 882.1480
Classification Product Code: GWG
Date Received: 07/02/2020
Decision Date: 11/04/2020
Regulation Medical Specialty: Neurology
Device Name: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
Manufacturer: Rebound Therapeutics
Device Classification Name: Endoscope, Neurological
Regulation Number: 882.1480
Classification Product Code: GWG
Date Received: 07/02/2020
Decision Date: 11/04/2020
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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