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510(k) K213946

Compass BDS Biliary Stent by Cook Ireland, Ltd. — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2022
Date Received
December 17, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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  • K182980 — Zilver 518 Biliary Stent, Zilver 635 Biliary Stent (November 16, 2018)
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  • K172057 — Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushin (March 9, 2018)
  • K172044 — Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Bilia (February 27, 2018)
  • K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression Set (August 1, 2017)

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