ODE — Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) Class II
FDA product code ODE covers "Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |