EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES— 510(k) K071651
Substantially EquivalentEndogastric Solutions, Inc.
FDA 510(k) clearance K071651 for EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES, Substantially Equivalent on 2007-09-14. 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
- Traditional
- Location
- Redmond, WA, US
Recent devices under product code ODE
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- K172811 — EsophyX Z, EsophyX2 HD
- K171307 — EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
- K160960 — EsophyX® Z Device with SerosaFuse Fasteners and Accessories
More clearances from Endogastric Solutions, Inc.
view all- K143645 — EsophyX® Z Fastener Delivery Device
- K142113 — ESOPHYX2 HD
- K092400 — ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
- K091832 — ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
- K073644 — ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.