Endoventions Alimaxx-E Esophageal Stent System
FDA 510(k) K051621 · Alveolus, Inc.
510(k) numberK051621
Submission
- Device name
- Endoventions Alimaxx-E Esophageal Stent System
- Applicant
- Alveolus, Inc.
Charlotte, NC, US - Received
- June 20, 2005
- Decision date
- July 11, 2005
- 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 |
| 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 |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K083625 | Aero DV Tracheobronchial Stent SystemJCT · Traditional | 03/11/2009SESU |
| K082284 | Aero Tracheobronchial Stent Technology SystemJCT · Traditional | 11/20/2008SESU |
| K080838 | Alveolus Alimaxx-E Esophageal Stent SystemESW · Special | 04/24/2008SE |
| K072720 | Alimaxx-B Uncovered Biliary Stent SystemFGE · Traditional | 04/11/2008SESU |
| K071604 | Alveolus Aero DV Tracheobronchial Stent SystemJCT · Traditional | 09/19/2007SESU |
| K062511 | Aero Tracheobronchial Stent System, Model 90129-2XXJCT · Traditional | 01/31/2007SESU |
| K060239 | Aleolus/Enoventions,Alimaxx-E DV Esophageal Stent SystemESW · Traditional | 03/22/2006SE |
| K033990 | Alveolus Inc. Tb-Sts Tracheobronchial Stent SystemJCT · Special | 05/12/2004SE |
| K033053 | Alveolus, Tb-Sts Tracheobronchial Stent SystemJCT · Traditional | 02/25/2004SE |
| K032744 | Alveolus Inc., Tb-Sts Tracheobronchial Stent SystemJCT · Traditional | 11/13/2003SE |
Questions and answers
When was Endoventions Alimaxx-E Esophageal Stent System cleared by the FDA?
Endoventions Alimaxx-E Esophageal Stent System (K051621) received a 510(k) decision of Substantially Equivalent on July 11, 2005, 21 days after the submission was received.
What is the product code of K051621?
The FDA product code is ESW – Prosthesis, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 878.3610.