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510(k) K190141

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2019
Date Received
January 29, 2019
Clearance Type
Special
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

Other clearances by M.I. Tech Co., Ltd.

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  • K201160 — HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (July 23, 2021)
  • K202973 — HANAROSTENT Benefit Biliary (NNN) (May 11, 2021)
  • K201342 — HANAROSTENT Trachea/Bronchium (CCC) (December 31, 2020)
  • K200860 — HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) (May 20, 2020)
  • K183396 — HANAROSTENT FASTTM Biliary (NNN) (February 11, 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)
  • K160893 — HANAROCare ReJu (July 27, 2016)

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)
  • K200257 — WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Du (April 17, 2020)
  • 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)