FDA 510(k) Applications Submitted by In Ho Kim
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160991 |
04/08/2016 |
Neo GBR System |
NEOBIOTECH CO., LTD. |
| K180180 |
01/23/2018 |
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) |
M.I. Tech Co., Ltd. |
| K190141 |
01/29/2019 |
HANAROSTENT LowAx Colon/Rectum (NNN) |
M.I.Tech Co., Ltd. |
| K200860 |
04/01/2020 |
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) |
M.I. Tech Co., Ltd |
| K201160 |
04/30/2020 |
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) |
M.I. Tech Co., Ltd |
| K201342 |
05/20/2020 |
HANAROSTENT Trachea/Bronchium (CCC) |
M.I. Tech Co., Ltd. |
| K202973 |
09/30/2020 |
HANAROSTENT Benefit Biliary (NNN) |
M.I.Tech Co., Ltd. |
| K183396 |
12/07/2018 |
HANAROSTENT FASTTM Biliary (NNN) |
M.I.Tech Co., Ltd. |
| K183616 |
12/26/2018 |
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) |
M.I. Tech Co., Ltd. |
| K232085 |
07/13/2023 |
DVAS (DVAS-M, DVAS-W) |
GENORAY CO., Ltd |
| K232158 |
07/20/2023 |
GenX-CR |
Genoray Co., Ltd. |
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