# M.I.Tech Co., Ltd.

- Location (FDA's records): Pyeongtaek-Si, KR
- FDA decisions: 14 (2008–2025): 14 510(k) clearances
- Product codes: ESW (6), FGE (3), MQR (3), JCT (1), NUH (1)
- 510(k) review time since 2016: median 84 days, against 139 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 16 (7 its own); citations of its devices by later devices: 15 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 4 (https://510kreport.com/company/boston-scientific)
- Taewoong Medical Co., Ltd.: 2 (https://510kreport.com/company/taewoong-medical)
- Micro-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/micro-tech-nanjing)
- Endochoice, Inc.: 1 (https://510kreport.com/company/endochoice)
- Prospera Corporation: 1 (https://510kreport.com/company/prospera)

## Firms that cite its devices most
- Taewoong Medical Co., Ltd.: 3 (https://510kreport.com/company/taewoong-medical)
- Shenzhen Kentro Medical Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-kentro-medical-electronics)
- Endochoice, Inc.: 1 (https://510kreport.com/company/endochoice)
- Micro-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/micro-tech-nanjing)
- S&G Biotech, Inc.: 1 (https://510kreport.com/company/s-g-biotech)

## Its most-cited devices
- K072094: Choostent (2008), cited by 3
- K111149: Hanarostent Biliary (NNN) (2011), cited by 3
- K201160: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (2021), cited by 2
- K183616: HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (2019), cited by 2
- K160893: HANAROCare ReJu (2016), cited by 2
- K202973: HANAROSTENT Benefit Biliary (NNN) (2021), cited by 1

## Recent decisions
- K253327: HANAROSTENT Esophagus Upper (CCC) (Oct 30, 2025)
- K213251: HANAROSTENT Esophagus Asymmetric (CCC) (Nov 18, 2021)
- K201160: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (Jul 23, 2021)
- K202973: HANAROSTENT Benefit Biliary (NNN) (May 11, 2021)
- K201342: HANAROSTENT Trachea/Bronchium (CCC) (Dec 31, 2020)
- K200860: HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) (May 20, 2020)
- K190141: HANAROSTENT LowAx Colon/Rectum (NNN) (Mar 7, 2019)
- K183396: HANAROSTENT FASTTM Biliary (NNN) (Feb 11, 2019)

Source page: https://510kreport.com/company/mitech