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510(k) K180180

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

K180180 is an FDA 510(k) premarket notification submitted by M.I.Tech Co., Ltd. for the device "HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)". The FDA issued a decision of Substantially Equivalent on November 2, 2018. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. M.I.Tech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2018
Date Received
January 23, 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

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

  • K253327 — HANAROSTENT Esophagus Upper (CCC) (October 30, 2025)
  • K213251 — HANAROSTENT Esophagus Asymmetric (CCC) (November 18, 2021)
  • 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)
  • K190141 — HANAROSTENT LowAx Colon/Rectum (NNN) (March 7, 2019)
  • K183396 — HANAROSTENT FASTTM Biliary (NNN) (February 11, 2019)
  • K183616 — HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (January 10, 2019)
  • 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)
  • K190141 — HANAROSTENT LowAx Colon/Rectum (NNN) (March 7, 2019)
  • K183616 — HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (January 10, 2019)
  • 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)

FDA data resources