Chrysalis Intelligence · Sponsors · M.I.Tech Co., Ltd.

M.I.Tech Co., Ltd.

Pyeongtaek-Si, KR · 6 510(k) clearances

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Total clearances
6
2020-05-20 → 2025-10-30
Last 12 months
1
Product codes
3
Most recent
2025-10-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ESW Prosthesis, Esophageal Class II General, Plastic Surgery 4 2025-10-30
FGE Stents, Drains And Dilators For The Biliary Ducts Class II Gastroenterology, Urology 1 2021-05-11
JCT Prosthesis, Tracheal, Expandable Class II General, Plastic Surgery 1 2020-12-31
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2025-10-30 K253327 HANAROSTENT Esophagus Upper (CCC) ESW Class II General, Plastic Surgery
2021-11-18 K213251 HANAROSTENT Esophagus Asymmetric (CCC) ESW Class II General, Plastic Surgery
2021-07-23 K201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) ESW Class II General, Plastic Surgery
2021-05-11 K202973 HANAROSTENT Benefit Biliary (NNN) FGE Class II Gastroenterology, Urology
2020-12-31 K201342 HANAROSTENT Trachea/Bronchium (CCC) JCT Class II General, Plastic Surgery
2020-05-20 K200860 HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) ESW Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence