Wallstent Esophageal Prosthesis (Double)

FDA 510(k) K940396 · Boston Scientific Scimed, Inc.

Substantially Equivalent

510(k) numberK940396

Submission

Device name
Wallstent Esophageal Prosthesis (Double)
Applicant
Boston Scientific Scimed, Inc.
Plymouth, MN, US
Received
January 27, 1994
Decision date
October 3, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special Boston Scientific Corporation07/10/2026SE
K253327HANAROSTENT Esophagus Upper (CCC)ESW · Special M.I.Tech Co., Ltd.10/30/2025SE
K243619Niti-S Esophageal Stent; Esophageal TTS StentESW · Traditional Taewoong Medical Co., Ltd.10/30/2025SE
K251265Resilience Fully Covered Esophageal Stent SystemESW · Traditional Merit Medical Systems, Inc.07/23/2025SE
K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemESW · Traditional Boston Scientific04/29/2024SE
K233837Agile Esophageal Stent SystemESW · Traditional Boston Scientific Corporation04/04/2024SE
K240522Esophageal TTS StentESW · Special Taewoong Medical03/22/2024SE
K223266Hilzo Esophageal StentsESW · Traditional Thoracent, Inc.01/16/2024SE
K221482Esophageal TTS StentESW · Special Taewoong Medical Co., Ltd.06/22/2022SE
K211960Agile Esophageal OTW Stent SystemESW · Traditional Boston Scientific Corporation11/22/2021SE

More from Boston Scientific Corporation

510(k)DeviceDecision
K041727Modification to Atlantis PV Imaging Catheter, Model 36456OBJ · Special 07/23/2004SE
K030617PT2 Guide Wire and Addwire Extension WireDQX · Abbreviated 05/21/2003SE
K024048Modification to Boston Scientific Express Biliary LD Premounted Stent SystemFGE · Special 01/06/2003SESU
K021735Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterDQY · Traditional 08/08/2002SE
K021901Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery SystemJCT · Special 07/09/2002SE
K012822Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model…FGE · Special 10/24/2001SESU
K012216Niroyal Biliary Premounted Stent SystemFGE · Special 08/17/2001SESU
K000743Boston Scientific Scimed Atlantis Coronary Imaging Catheter, Model C4020DQO · Traditional 09/06/2000SE
K000001Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery SystemJCT · Traditional 06/05/2000SE
K000956Modification to Scimed 6F Impulse Angiographic CathatersDQO · Special 04/21/2000SE

Questions and answers

When was Wallstent Esophageal Prosthesis (Double) cleared by the FDA?

Wallstent Esophageal Prosthesis (Double) (K940396) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 249 days after the submission was received.

What is the product code of K940396?

The FDA product code is ESW – Prosthesis, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 878.3610.