EsophyX® Z Device with SerosaFuse Fasteners and Accessories— 510(k) K160960
Substantially EquivalentEndogastric Solutions, Inc.
FDA 510(k) clearance K160960 for EsophyX® Z Device with SerosaFuse Fasteners and Accessories, Substantially Equivalent on 2016-05-01. 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
- Redmond, WA, US
Recent devices under product code ODE
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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
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