Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ODE · Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
72 daysmedian FDA review time
251 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233240 | GERDX-System | G-Surg GmbH | 2024-06-21 | 267 | 0 |
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2024-04-26 | 28 | 2 |
| K172811 | EsophyX Z, EsophyX2 HD | Endogastric Solutions, Inc. | 2017-10-19 | 31 | 0 |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2017-06-22 | 50 | 0 |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2016-05-01 | 26 | 0 |
| K151001 | MUSE System | Medigus , Ltd. | 2015-06-05 | 51 | 0 |
| K143645 | EsophyX® Z Fastener Delivery Device | Endogastric Solutions, Inc. | 2015-03-04 | 72 | 0 |
| K143634 | MUSE System | Medigus , Ltd. | 2015-01-20 | 29 | 0 |
| K142113 | ESOPHYX2 HD | Endogastric Solutions, Inc. | 2014-09-30 | 57 | 0 |
| K132151 | SRS ENDOSCOPIC STAPLING SYSTEM | Medigus , Ltd. | 2014-03-19 | 251 | 0 |
| K120299 | SRS ENDOSCOPIC STAPLING SYSTEM | Medigus , Ltd. | 2012-05-18 | 108 | 0 |
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTEN | Endogastric Solutions, Inc. | 2009-11-06 | 92 | 2 |
| K072125 | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRU | Ndo Surgical, Inc. | 2007-10-18 | 77 | 0 |
| K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | Ndo Surgical, Inc. | 2007-09-18 | 104 | 0 |
| K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DE | Endogastric Solutions, Inc. | 2007-09-14 | 88 | 0 |
| K032820 | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM | Ndo Surgical, Inc. | 2003-10-23 | 43 | 1 |
| K031262 | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 | Ndo Surgical, Inc. | 2003-05-23 | 32 | 0 |
| K023234 | ENDOSCOPIC PLICATION SYSTEM | Ndo Surgical, Inc. | 2003-04-17 | 202 | 0 |
| K003956 | BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 | C.R. Bard, Inc. | 2001-01-05 | 15 | 0 |
| K994290 | BARD ENDOSCOPIC SUTURING SYSTEM | C.R. Bard, Inc. | 2000-03-20 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda