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510(k) K163468

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered by Cook Ireland, Ltd. — Product Code MUM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2017
Date Received
December 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Metallic, Expandable, Duodenal
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

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  • K172044 — Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Bilia (February 27, 2018)

Other clearances for product code MUM

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  • K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (June 14, 2023)
  • K101530 — EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-1 (March 29, 2011)
  • K062750 — WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M005650 (December 4, 2006)
  • K980113 — WALLSTENT ENTERAL ENDOPROSTHESIS (April 3, 1998)