Ultraflex Esophageal NG Stent System
FDA 510(k) K130004 · Boston Scientific Corporation
510(k) numberK130004
Submission
- Device name
- Ultraflex Esophageal NG Stent System
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- January 2, 2013
- Decision date
- December 6, 2013
- 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 |
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| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | 08/26/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | 08/21/2026SE |
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | 08/04/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
Questions and answers
When was Ultraflex Esophageal NG Stent System cleared by the FDA?
Ultraflex Esophageal NG Stent System (K130004) received a 510(k) decision of Substantially Equivalent on December 6, 2013, 338 days after the submission was received.
What is the product code of K130004?
The FDA product code is ESW – Prosthesis, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 878.3610.