Hilzo Esophageal Stents
FDA 510(k) K223266 · Thoracent, Inc.
510(k) numberK223266
Submission
- Device name
- Hilzo Esophageal Stents
- Applicant
- Thoracent, Inc.
Huntington, NY, US - Received
- October 24, 2022
- Decision date
- January 16, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K240522 | Esophageal TTS StentESW · Special | Taewoong Medical | 03/22/2024SE |
| 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 |
Questions and answers
When was Hilzo Esophageal Stents cleared by the FDA?
Hilzo Esophageal Stents (K223266) received a 510(k) decision of Substantially Equivalent on January 16, 2024, 449 days after the submission was received.
What is the product code of K223266?
The FDA product code is ESW – Prosthesis, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 878.3610.