510(k) K200860
- Device
- HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
- Applicant
- M.I. Tech Co., Ltd
- 510(k) number
- K200860
- Product code
- ESW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-20
- Date received
- 2020-04-01
- Regulation
- 878.3610
- Classification name
- Prosthesis, Esophageal
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Inae Kim
- Address
- 174 Habuk 2-Gil, Jinwi-Myeon Pyeongtaek-Si KR 17706 17706
FDA Registration Numbers#
- 3010173425
- 3003902943
- 3009906660
- 3004837686
- 3015309643
- 3005580113
- 3010665433
- 3000247987
- 3013337852
- 3006950086
- 3001845648
- 3010273872
- 3033589330
- 3008146331
- 3005099803
- 3002807314
- 3014172183
- 1721676
- 3005987240
- 3006017180
- 1000121056
- 1721504
- 3011458193
- 1724474
- 3040096051
- 3015225571
- 3013440400
- 3012536737
- 9681260
- 3009526575
- 1225687
Source Documents#
Other 510(k) Records For Product Code ESW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253327 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | 2025-10-30 |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2025-10-30 |
| K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | 2025-07-23 |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | 2024-04-29 |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024-04-04 |
| K240522 | Esophageal TTS Stent | Taewoong Medical | 2024-03-22 |
| K223266 | Hilzo Esophageal Stents | Thoracent, Inc. | 2024-01-16 |
| K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2022-06-22 |
| K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021-11-22 |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | 2021-11-18 |
| K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2021-10-08 |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021-07-23 |
| K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2019-05-29 |
| K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018-09-21 |
| K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018-05-18 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases