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510(k) K212582

SpyGlass Discover Balloon Dilation Catheter by Boston Scientific Corporation — Product Code GCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2022
Date Received
August 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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Other clearances for product code GCA

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  • K200173 — Stone Retrieval Balloon (May 1, 2020)
  • K200247 — Fusion Quattro Extraction Balloon (February 27, 2020)
  • K193344 — Tri-Ex Extraction Balloon with Multiple Sizing (December 13, 2019)
  • K173659 — Howell D.A.S.H Extraction Balloon with Multiple Sizing (July 6, 2018)
  • K173414 — Advance Biliary Balloon Catheter (June 22, 2018)
  • K170292 — Tri-Ex Extraction Balloon With Multiple Sizing (September 20, 2017)
  • K063677 — FUSION QUATTRO EXTRACTION BALLOON XL (January 5, 2007)
  • K040129 — TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING (February 27, 2004)