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510(k) K183636

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller by Boston Scientific Corporation — Product Code FBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2019
Date Received
December 26, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Choledochoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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  • K241444 — Biliary Pancreaticobiliary Scope System (January 21, 2025)
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  • K223741 — Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Fl (June 22, 2023)
  • K222261 — Flexible Video-Choledochoscope System (April 20, 2023)
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