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510(k) K183616

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) by M.I. Tech Co., Ltd. — Product Code MQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2019
Date Received
December 26, 2018
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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  • K201342 — HANAROSTENT Trachea/Bronchium (CCC) (December 31, 2020)
  • K200860 — HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) (May 20, 2020)
  • K190141 — HANAROSTENT LowAx Colon/Rectum (NNN) (March 7, 2019)
  • K183396 — HANAROSTENT FASTTM Biliary (NNN) (February 11, 2019)
  • K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NN (November 2, 2018)
  • K160893 — HANAROCare ReJu (July 27, 2016)

Other clearances for product code MQR

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  • K201159 — WallFlex Colonic Stent System with Anchor Lock Delivery System (August 17, 2020)
  • K200257 — WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Du (April 17, 2020)
  • K190141 — HANAROSTENT LowAx Colon/Rectum (NNN) (March 7, 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)