FDA 510(k) Applications for Medical Device Product Code "ODE"
(Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K003956 | C.R. BARD, INC. | BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 | 01/05/2001 |
| K994290 | C.R. BARD, INC. | BARD ENDOSCOPIC SUTURING SYSTEM | 03/20/2000 |
| K071651 | ENDOGASTRIC SOLUTIONS, INC. | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES | 09/14/2007 |
| K092400 | ENDOGASTRIC SOLUTIONS, INC. | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 | 11/06/2009 |
| K172811 | EndoGastric Solutions, Inc. | EsophyX Z, EsophyX2 HD | 10/19/2017 |
| K160960 | ENDOGASTRIC SOLUTIONS, INC. | EsophyX« Z Device with SerosaFuse Fasteners and Accessories | 05/01/2016 |
| K143645 | ENDOGASTRIC SOLUTIONS, INC. | EsophyX« Z Fastener Delivery Device | 03/04/2015 |
| K142113 | ENDOGASTRIC SOLUTIONS, INC. | ESOPHYX2 HD | 09/30/2014 |
| K171307 | EndoGastric Solutions, Inc. | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | 06/22/2017 |
| K143634 | MEDIGUS LTD. | MUSE System | 01/20/2015 |
| K151001 | MEDIGUS LTD. | MUSE System | 06/05/2015 |
| K120299 | MEDIGUS, LTD. | SRS ENDOSCOPIC STAPLING SYSTEM | 05/18/2012 |
| K132151 | MEDIGUS, LTD. | SRS ENDOSCOPIC STAPLING SYSTEM | 03/19/2014 |
| K023234 | NDO SURGICAL, INC. | ENDOSCOPIC PLICATION SYSTEM | 04/17/2003 |
| K072125 | NDO SURGICAL, INC. | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT | 10/18/2007 |
| K031262 | NDO SURGICAL, INC. | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 | 05/23/2003 |
| K071553 | NDO SURGICAL, INC. | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | 09/18/2007 |
| K032820 | NDO SURGICAL, INC. | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM | 10/23/2003 |
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