EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories— 510(k) K171307
Substantially EquivalentEndogastric Solutions, Inc.
FDA 510(k) clearance K171307 for EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories, Substantially Equivalent on 2017-06-22. Applicant: Endogastric Solutions, Inc..
Clearance details
- Applicant
- Endogastric Solutions, Inc.
- Product code
- Code ODE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, WA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.