ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
FDA 510(k) clearance K092400 · decided 2009-11-06
Clearance details
- K-number
- K092400
- Device name
- ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
- Applicant
- Endogastric Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-06
- Decision date
- 2009-11-06
- Days to decision
- 92 days
- Clearance type
- Special
- Product code
- ODE
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GERDX-System (K233240) | G-Surg GmbH | 2024-06-21 |
| EsophyX Z+ Device with SerosaFuse Fasteners and Accessories (K240879) | Endogastric Solutions, Inc. | 2024-04-26 |
| EsophyX Z, EsophyX2 HD (K172811) | Endogastric Solutions, Inc. | 2017-10-19 |
| EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories (K171307) | Endogastric Solutions, Inc. | 2017-06-22 |
| EsophyX® Z Device with SerosaFuse Fasteners and Accessories (K160960) | Endogastric Solutions, Inc. | 2016-05-01 |
| MUSE System (K151001) | Medigus , Ltd. | 2015-06-05 |
| EsophyX® Z Fastener Delivery Device (K143645) | Endogastric Solutions, Inc. | 2015-03-04 |
| MUSE System (K143634) | Medigus , Ltd. | 2015-01-20 |
| ESOPHYX2 HD (K142113) | Endogastric Solutions, Inc. | 2014-09-30 |
| SRS ENDOSCOPIC STAPLING SYSTEM (K132151) | Medigus , Ltd. | 2014-03-19 |
| SRS ENDOSCOPIC STAPLING SYSTEM (K120299) | Medigus , Ltd. | 2012-05-18 |
| ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT (K072125) | Ndo Surgical, Inc. | 2007-10-18 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 a recall (Z-1982-2013) | Endogastric Solutions Inc | 2013-08-17 |
| EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part numbe recall (Z-1136-2013) | Endogastric Solutions Inc | 2013-04-17 |