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510(k) K200257

WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System by Boston Scientific Corporation — Product Code MQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2020
Date Received
February 3, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code MQR

  • K234046 — WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodena (March 8, 2024)
  • K201159 — WallFlex Colonic Stent System with Anchor Lock Delivery System (August 17, 2020)
  • K190141 — HANAROSTENT LowAx Colon/Rectum (NNN) (March 7, 2019)
  • K183616 — HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (January 10, 2019)
  • K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NN (November 2, 2018)
  • K113510 — EVOLUTION COLONIC STENT SYSTEM (May 17, 2012)
  • K061877 — WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM (September 15, 2006)
  • K060323 — ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 (May 12, 2006)
  • K042065 — WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM (September 30, 2004)
  • K030769 — ULTRAFLEX PRECISION COLONIC STENT (July 14, 2003)