ODE — Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) Class II
Classification Details
- Product Code
- ODE
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233240 | g-surg | GERDX-System | June 21, 2024 |
| K240879 | endogastric solutions | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | April 26, 2024 |
| K172811 | endogastric solutions | EsophyX Z, EsophyX2 HD | October 19, 2017 |
| K171307 | endogastric solutions | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device w | June 22, 2017 |
| K160960 | endogastric solutions | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | May 1, 2016 |
| K151001 | medigus | MUSE System | June 5, 2015 |
| K143645 | endogastric solutions | EsophyX® Z Fastener Delivery Device | March 4, 2015 |
| K143634 | medigus | MUSE System | January 20, 2015 |
| K142113 | endogastric solutions | ESOPHYX2 HD | September 30, 2014 |
| K132151 | medigus | SRS ENDOSCOPIC STAPLING SYSTEM | March 19, 2014 |
| K120299 | medigus | SRS ENDOSCOPIC STAPLING SYSTEM | May 18, 2012 |
| K092400 | endogastric solutions | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, | November 6, 2009 |
| K072125 | ndo surgical | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT | October 18, 2007 |
| K071553 | ndo surgical | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | September 18, 2007 |
| K071651 | endogastric solutions | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIE | September 14, 2007 |
| K032820 | ndo surgical | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM | October 23, 2003 |
| K031262 | ndo surgical | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 | May 23, 2003 |
| K023234 | ndo surgical | ENDOSCOPIC PLICATION SYSTEM | April 17, 2003 |
| K003956 | c.r. bard | BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 | January 5, 2001 |
| K994290 | c.r. bard | BARD ENDOSCOPIC SUTURING SYSTEM | March 20, 2000 |