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FDA 510(k), K181977, WiScope Digital Endoscope System
FDA 510(k), K181977, WiScope Digital Endoscope System
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$149.00 USD
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510(K) Number: K181977
Device Name: WiScope Digital Endoscope System
Manufacturer: OTU Medical Inc.
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 07/24/2018
Decision Date: 08/14/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: WiScope Digital Endoscope System
Manufacturer: OTU Medical Inc.
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 07/24/2018
Decision Date: 08/14/2018
Regulation Medical Specialty: Gastroenterology/Urology
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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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