Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
FDA 510(k) clearance K233939 · decided 2024-04-29
Clearance details
- K-number
- K233939
- Device name
- Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2023-12-14
- Decision date
- 2024-04-29
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978) | Boston Scientific Corporation | 2026-07-10 |
| 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 |
| 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 |