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510(k) K202973

HANAROSTENT Benefit Biliary (NNN) by M.I. Tech Co., Ltd. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
May 11, 2021
Date Received
September 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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

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  • K213251 — HANAROSTENT Esophagus Asymmetric (CCC) (November 18, 2021)
  • K201160 — HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (July 23, 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)
  • K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NN (November 2, 2018)
  • K160893 — HANAROCare ReJu (July 27, 2016)

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  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
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