FDA Product Code
FDA Product Code ODE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233240 | GERDX-System | G-Surg GmbH | 2024-06-21 | Traditional | PDF ↗ |
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2024-04-26 | Special | PDF ↗ |
| K172811 | EsophyX Z, EsophyX2 HD | Endogastric Solutions, Inc. | 2017-10-19 | Traditional | PDF ↗ |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2017-06-22 | Traditional | PDF ↗ |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2016-05-01 | Special | PDF ↗ |
| K151001 | MUSE System | Medigus , Ltd. | 2015-06-05 | Special | PDF ↗ |
| K143645 | EsophyX® Z Fastener Delivery Device | Endogastric Solutions, Inc. | 2015-03-04 | Traditional | PDF ↗ |
| K143634 | MUSE System | Medigus , Ltd. | 2015-01-20 | Special | PDF ↗ |
| K142113 | ESOPHYX2 HD | Endogastric Solutions, Inc. | 2014-09-30 | Special | PDF ↗ |
| K132151 | SRS ENDOSCOPIC STAPLING SYSTEM | Medigus , Ltd. | 2014-03-19 | Traditional | PDF ↗ |
| K120299 | SRS ENDOSCOPIC STAPLING SYSTEM | Medigus , Ltd. | 2012-05-18 | Traditional | PDF ↗ |
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 | Endogastric Solutions, Inc. | 2009-11-06 | Special | PDF ↗ |
| K072125 | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT | Ndo Surgical, Inc. | 2007-10-18 | Traditional | PDF ↗ |
| K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | Ndo Surgical, Inc. | 2007-09-18 | Traditional | PDF ↗ |
| K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES | Endogastric Solutions, Inc. | 2007-09-14 | Traditional | PDF ↗ |
| K032820 | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM | Ndo Surgical, Inc. | 2003-10-23 | Special | PDF ↗ |
| K031262 | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 | Ndo Surgical, Inc. | 2003-05-23 | Special | PDF ↗ |
| K023234 | ENDOSCOPIC PLICATION SYSTEM | Ndo Surgical, Inc. | 2003-04-17 | Traditional | PDF ↗ |
| K003956 | BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 | C.R. Bard, Inc. | 2001-01-05 | Traditional | PDF ↗ |
| K994290 | BARD ENDOSCOPIC SUTURING SYSTEM | C.R. Bard, Inc. | 2000-03-20 | Traditional | PDF ↗ |
Product code ODE · Class II · Gastroenterology, Urology. Data: openFDA.