WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730— 510(k) K091510
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K091510 for WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730, Substantially Equivalent on 2009-06-26. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code ESW
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlboro, MA, US
Recent devices under product code ESW
view all- K261978 — WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System
- K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent
- K253327 — HANAROSTENT Esophagus Upper (CCC)
- K251265 — Resilience Fully Covered Esophageal Stent System
- K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
More clearances from Boston Scientific Corporation
view allAdverse events under product code ESW
product code ESW- Death
- 11
- Injury
- 353
- Malfunction
- 442
- Total
- 806
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.