Esophageal TTS Stent
FDA 510(k) K240522 · Taewoong Medical
510(k) numberK240522
Submission
- Device name
- Esophageal TTS Stent
- Applicant
- Taewoong Medical
Gyeonggi-Do, KR - Received
- February 23, 2024
- Decision date
- March 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ESW – Prosthesis, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code ESW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | Boston Scientific Corporation | 07/10/2026SE |
| K253327 | HANAROSTENT Esophagus Upper (CCC)ESW · Special | M.I.Tech Co., Ltd. | 10/30/2025SE |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS StentESW · Traditional | Taewoong Medical Co., Ltd. | 10/30/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | Merit Medical Systems, Inc. | 07/23/2025SE |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemESW · Traditional | Boston Scientific | 04/29/2024SE |
| K233837 | Agile Esophageal Stent SystemESW · Traditional | Boston Scientific Corporation | 04/04/2024SE |
| K223266 | Hilzo Esophageal StentsESW · Traditional | Thoracent, Inc. | 01/16/2024SE |
| K221482 | Esophageal TTS StentESW · Special | Taewoong Medical Co., Ltd. | 06/22/2022SE |
| K211960 | Agile Esophageal OTW Stent SystemESW · Traditional | Boston Scientific Corporation | 11/22/2021SE |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC)ESW · Special | M.I.Tech Co., Ltd. | 11/18/2021SE |
More from M.I.Tech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260962 | SphincterotomeKNS · Traditional | 05/21/2026SE |
| K252648 | Niti-S SPAXUS StentPCU · Traditional | 03/13/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | 12/29/2025SESU |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS StentESW · Traditional | 10/30/2025SE |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentMUM · Special | 03/31/2025SE |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort StentMUM · Traditional | 06/14/2023SE |
| K223626 | Niti-S Biliary Speed D StentFGE · Traditional | 05/26/2023SESU |
| K223256 | Optimos CystotomeKNS · Traditional | 04/05/2023SE |
| K221482 | Esophageal TTS StentESW · Special | 06/22/2022SE |
| K221071 | Niti-S Biliary Slim M StentFGE · Traditional | 06/09/2022SESU |
Questions and answers
When was Esophageal TTS Stent cleared by the FDA?
Esophageal TTS Stent (K240522) received a 510(k) decision of Substantially Equivalent on March 22, 2024, 28 days after the submission was received.
What is the product code of K240522?
The FDA product code is ESW – Prosthesis, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 878.3610.