WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
FDA 510(k) clearance K261978 · decided 2026-07-10
Clearance details
- K-number
- K261978
- Device name
- WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2026-06-12
- Decision date
- 2026-07-10
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Niti-S Esophageal Stent; Esophageal TTS Stent (K243619) | Taewoong Medical Co., Ltd. | 2025-10-30 |
| HANAROSTENT Esophagus Upper (CCC) (K253327) | M.I.Tech Co., Ltd. | 2025-10-30 |
| Resilience Fully Covered Esophageal Stent System (K251265) | Merit Medical Systems, Inc. | 2025-07-23 |
| Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (K233939) | Boston Scientific | 2024-04-29 |
| Agile Esophageal Stent System (K233837) | Boston Scientific Corporation | 2024-04-04 |
| Esophageal TTS Stent (K240522) | Taewoong Medical | 2024-03-22 |
| Hilzo Esophageal Stents (K223266) | Thoracent, Inc. | 2024-01-16 |
| Esophageal TTS Stent (K221482) | Taewoong Medical Co., Ltd. | 2022-06-22 |
| Agile Esophageal OTW Stent System (K211960) | Boston Scientific Corporation | 2021-11-22 |
| HANAROSTENT Esophagus Asymmetric (CCC) (K213251) | M.I.Tech Co., Ltd. | 2021-11-18 |
| Esophageal TTS Stent (K211706) | Taewoong Medical Co., Ltd. | 2021-10-08 |
| HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (K201160) | M.I.Tech Co., Ltd. | 2021-07-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Axonics Sacral Neuromodulation System (P190006/S101) | Boston Scientific Corporation | 2025-12-19 |
| Axonics Sacral Neuromodulation System (P180046/S101) | Boston Scientific Corporation | 2025-12-19 |
| SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S110) | Boston Scientific Corporation | 2025-10-29 |
| Innova Vascular Self-Expanding Stent System (P140028/S084) | Boston Scientific Corporation | 2025-10-24 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S039) | Boston Scientific Corporation | 2025-10-24 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S007) | Boston Scientific Corporation | 2025-10-24 |
| ENROUTE® Transcarotid Stent System (P140026/S032) | Boston Scientific Corporation | 2025-10-23 |
| A209 SICD Gen 2,A219 SICD MRI (P110042/S206) | Boston Scientific Corporation | 2025-10-22 |