HANAROSTENT Trachea/Bronchium (CCC)
FDA 510(k) K201342 · M.I.Tech Co., Ltd.
510(k) numberK201342
Submission
- Device name
- HANAROSTENT Trachea/Bronchium (CCC)
- Applicant
- M.I.Tech Co., Ltd.
Pyeongtaek-Si, KR - Received
- May 20, 2020
- Decision date
- December 31, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCT – Prosthesis, Tracheal, Expandable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3720
- Specialty
- General, Plastic Surgery
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code JCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230269 | Ultraflex Tracheobronchial Stent SystemJCT · Special | Boston Scientific Corporation | 07/14/2023SE |
| K220424 | Through the Scope Tracheal Stent SystemJCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 07/08/2022SE |
| K212403 | Tracheal Stent System (Y-Shaped)JCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 10/30/2021SE |
| K202204 | Tracheal Stent SystemJCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 09/01/2021SE |
| K181200 | AEROmini Tracheobronchial Stent SystemJCT · Traditional | Merit Medical Systems, Inc. | 09/21/2018SE |
| K152842 | Wallstent RP Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis TracheobronchialJCT · Traditional | Boston Scientific Corporation | 05/19/2016SE |
| K140382 | Aeromini Tracheobronchial Stent TechnologyJCT · Traditional | Merit Medical Systems, Inc. | 11/25/2014SE |
| K140472 | Bonastent Tracheal / BronchialJCT · Traditional | Endochoice, Inc. | 10/17/2014SE |
| K141584 | Ultraflex Tracheobronchial Covered Stent SystemJCT · Traditional | Boston Scientific Corporation | 10/16/2014SE |
| K121048 | Ultraflex Tracheobronchial Stent System- Sterile UncoveredJCT · Traditional | Boston Scientific Corp | 08/03/2012SE |
More from Boston Scientific Corp
| 510(k) | Device | Decision |
|---|---|---|
| K253327 | HANAROSTENT Esophagus Upper (CCC)ESW · Special | 10/30/2025SE |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC)ESW · Special | 11/18/2021SE |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)ESW · Traditional | 07/23/2021SE |
| K202973 | HANAROSTENT Benefit Biliary (NNN)FGE · Traditional | 05/11/2021SESU |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)ESW · Traditional | 05/20/2020SE |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN)MQR · Special | 03/07/2019SE |
| K183396 | HANAROSTENT FASTTM Biliary (NNN)FGE · Traditional | 02/11/2019SESU |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR · Traditional | 01/10/2019SE |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)MQR · Traditional | 11/02/2018SE |
| K160893 | HANAROCare ReJuNUH · Traditional | 07/27/2016SE |
Questions and answers
When was HANAROSTENT Trachea/Bronchium (CCC) cleared by the FDA?
HANAROSTENT Trachea/Bronchium (CCC) (K201342) received a 510(k) decision of Substantially Equivalent on December 31, 2020, 225 days after the submission was received.
What is the product code of K201342?
The FDA product code is JCT – Prosthesis, Tracheal, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3720.