Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
The Endoscopic Suture/Plication System for Gastroesophageal Reflux Disease (GERD) (product code ODE) is a gastroenterology and urology device used endoscopically to treat chronic GERD symptoms by either approximating tissue with sutures or plicating (folding) tissue with an implanted fastener, reinforcing the lower esophageal sphincter area. The procedure is performed without open surgery. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requires 510(k) clearance, and carries an implant flag indicating that a tissue-plicating component is left in the body.
Basic Information
- Product Code
- ODE
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 20 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233240 | GERDX-System | Jun 21, 2024 | Substantially Equivalent | G-Surg GmbH |
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Apr 26, 2024 | Substantially Equivalent | EndoGastric Solutions, Inc. |
| K172811 | EsophyX Z, EsophyX2 HD | Oct 19, 2017 | Substantially Equivalent | EndoGastric Solutions, Inc. |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | Jun 22, 2017 | Substantially Equivalent | EndoGastric Solutions, Inc. |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | May 01, 2016 | Substantially Equivalent | ENDOGASTRIC SOLUTIONS, INC. |
| K151001 | MUSE System | Jun 05, 2015 | Substantially Equivalent | MEDIGUS LTD. |
| K143645 | EsophyX® Z Fastener Delivery Device | Mar 04, 2015 | Substantially Equivalent | ENDOGASTRIC SOLUTIONS, INC. |
| K143634 | MUSE System | Jan 20, 2015 | Substantially Equivalent | MEDIGUS LTD. |
| K142113 | ESOPHYX2 HD | Sep 30, 2014 | Substantially Equivalent | ENDOGASTRIC SOLUTIONS, INC. |
| K132151 | SRS ENDOSCOPIC STAPLING SYSTEM | Mar 19, 2014 | Substantially Equivalent | MEDIGUS, LTD. |
| K120299 | SRS ENDOSCOPIC STAPLING SYSTEM | May 18, 2012 | Substantially Equivalent | MEDIGUS, LTD. |
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 | Nov 06, 2009 | Substantially Equivalent | ENDOGASTRIC SOLUTIONS, INC. |
| K072125 | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT | Oct 18, 2007 | Substantially Equivalent | NDO SURGICAL, INC. |
| K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | Sep 18, 2007 | Substantially Equivalent | NDO SURGICAL, INC. |
| K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES | Sep 14, 2007 | Substantially Equivalent | ENDOGASTRIC SOLUTIONS, INC. |
| K032820 | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM | Oct 23, 2003 | Substantially Equivalent | NDO SURGICAL, INC. |
| K031262 | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 | May 23, 2003 | Substantially Equivalent | NDO SURGICAL, INC. |
| K023234 | ENDOSCOPIC PLICATION SYSTEM | Apr 17, 2003 | Substantially Equivalent | NDO SURGICAL, INC. |
| K003956 | BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 | Jan 05, 2001 | Substantially Equivalent | C.R. BARD, INC. |
| K994290 | BARD ENDOSCOPIC SUTURING SYSTEM | Mar 20, 2000 | Substantially Equivalent | C.R. BARD, INC. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.