HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
FDA 510(k) K180180 · M.I.Tech Co., Ltd.
510(k) numberK180180
Submission
- Device name
- HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
- Applicant
- M.I.Tech Co., Ltd.
Pyeongtaek-Si, KR - Received
- January 23, 2018
- Decision date
- November 2, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQR – Stent, Colonic, Metallic, Expandable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code MQR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…MQR · Special | Boston Scientific Corporation | 03/08/2024SE |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corporation | 08/17/2020SE |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…MQR · Traditional | Boston Scientific Corporation | 04/17/2020SE |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN)MQR · Special | M.I.Tech Co., Ltd. | 03/07/2019SE |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR · Traditional | M.I.Tech Co., Ltd. | 01/10/2019SE |
| K113510 | Evolution Colonic Stent SystemMQR · Traditional | Cook Ireland, Ltd. | 05/17/2012SE |
| K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/15/2006SE |
| K060323 | Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380MQR · Traditional | Boston Scientific Corporation | 05/12/2006SE |
| K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/30/2004SE |
| K030769 | Ultraflex Precision Colonic StentMQR · Traditional | Boston Scientific Corp | 07/14/2003SE |
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 |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC)JCT · Traditional | 12/31/2020SE |
| 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 |
| K160893 | HANAROCare ReJuNUH · Traditional | 07/27/2016SE |
Questions and answers
When was HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) cleared by the FDA?
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (K180180) received a 510(k) decision of Substantially Equivalent on November 2, 2018, 283 days after the submission was received.
What is the product code of K180180?
The FDA product code is MQR – Stent, Colonic, Metallic, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3610.