Panels › Gastroenterology, Urology › Product code ODE · Class 2
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Regulation 876.1500
0510(k)s in 12 months (20 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in ODE
| Company | 510(k)s | Recalls |
|---|---|---|
| Endogastric Solutions, Inc. | 8 | 2 |
| Ndo Surgical, Inc. | 5 | 0 |
| Medigus , Ltd. | 4 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Merit Medical Systems, Inc. | 0 | 2 |
| G-Surg GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 2024 | K233240 | GERDX-System G-Surg GmbH, DE | ODE |
| Apr 26, 2024 | K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories Endogastric Solutions, Inc. | ODE |
| Oct 19, 2017 | K172811 | EsophyX Z, EsophyX2 HD Endogastric Solutions, Inc. | ODE |
| Jun 22, 2017 | K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories Endogastric Solutions, Inc. | ODE |
| May 1, 2016 | K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories Endogastric Solutions, Inc. | ODE |
| Jun 5, 2015 | K151001 | MUSE System Medigus , Ltd., IL | ODE |
| Mar 4, 2015 | K143645 | EsophyX® Z Fastener Delivery Device Endogastric Solutions, Inc. | ODE |
| Jan 20, 2015 | K143634 | MUSE System Medigus , Ltd., IL | ODE |
| Sep 30, 2014 | K142113 | ESOPHYX2 HD Endogastric Solutions, Inc. | ODE |
| Mar 19, 2014 | K132151 | SRS ENDOSCOPIC STAPLING SYSTEM Medigus , Ltd. | ODE |
| May 18, 2012 | K120299 | SRS ENDOSCOPIC STAPLING SYSTEM Medigus , Ltd. | ODE |
| Nov 6, 2009 | K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 Endogastric Solutions, Inc. | ODE |
| Oct 18, 2007 | K072125 | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT Ndo Surgical, Inc. | ODE |
| Sep 18, 2007 | K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR Ndo Surgical, Inc. | ODE |
| Sep 14, 2007 | K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES Endogastric Solutions, Inc. | ODE |
| Oct 23, 2003 | K032820 | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM Ndo Surgical, Inc. | ODE |
| May 23, 2003 | K031262 | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 Ndo Surgical, Inc. | ODE |
| Apr 17, 2003 | K023234 | ENDOSCOPIC PLICATION SYSTEM Ndo Surgical, Inc. | ODE |
| Jan 5, 2001 | K003956 | BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 C.R. Bard, Inc. | ODE |
| Mar 20, 2000 | K994290 | BARD ENDOSCOPIC SUTURING SYSTEM C.R. Bard, Inc. | ODE |
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