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510(k) K201342

HANAROSTENT Trachea/Bronchium (CCC) by M.I.Tech Co., Ltd. — Product Code JCT

K201342 is an FDA 510(k) premarket notification submitted by M.I.Tech Co., Ltd. for the device "HANAROSTENT Trachea/Bronchium (CCC)". The FDA issued a decision of Substantially Equivalent on December 31, 2020. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. M.I.Tech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2020
Date Received
May 20, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Expandable
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
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)
  • 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)
  • 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 JCT

  • K230269 — Ultraflex™ Tracheobronchial Stent System (July 14, 2023)
  • K220424 — Through the Scope Tracheal Stent System (July 8, 2022)
  • K212403 — Tracheal Stent System (Y-Shaped) (October 30, 2021)
  • K202204 — Tracheal Stent System (September 1, 2021)
  • K181200 — AEROmini Tracheobronchial Stent System (September 21, 2018)
  • K152842 — WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOB (May 19, 2016)
  • K140382 — AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY (November 25, 2014)
  • K140472 — BONASTENT TRACHEAL / BRONCHIAL (October 17, 2014)
  • K141584 — ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (October 16, 2014)
  • K121048 — ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED (August 3, 2012)

FDA data resources