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510(k) K182980

Zilver 518 Biliary Stent, Zilver 635 Biliary Stent by Cook Ireland, Ltd. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
November 16, 2018
Date Received
October 29, 2018
Clearance Type
Special
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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  • K180868 — Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal B (July 6, 2018)
  • 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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