ESOPHYX2 HD— 510(k) K142113
Substantially EquivalentEndogastric Solutions, Inc.
FDA 510(k) clearance K142113 for ESOPHYX2 HD, Substantially Equivalent on 2014-09-30. Applicant: Endogastric Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Endogastric Solutions, Inc.
- Product code
- Code ODE
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gardnerville, NV, US
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More clearances from Endogastric Solutions, Inc.
view all- K143645 — EsophyX® Z Fastener Delivery Device
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- K091832 — ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
- K073644 — ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
- K071651 — EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.