FDA 510(k), K183636, SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

FDA 510(k), K183636, SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

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510(K) Number: K183636
Device Name: SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
Manufacturer: Boston Scientific Corporation
Device Classification Name: Choledochoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FBN
Date Received: 12/26/2018
Decision Date: 01/22/2019
Regulation Medical Specialty: Gastroenterology/Urology

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