Atlas FDA

ODE

20 FDA 510(k) clearances · Product code

72 daysmedian time to decision
251 days90th percentile
20clearances measured

FDA profile

Official device name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Flags
Implant
FDA definition
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
Adverse events (MAUDE)
2021: 24 · 2022: 16 · 2023: 28 · 2024: 41 · 2025: 39 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GERDX-System (K233240)G-Surg GmbH2024-06-21
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories (K240879)Endogastric Solutions, Inc.2024-04-26
EsophyX Z, EsophyX2 HD (K172811)Endogastric Solutions, Inc.2017-10-19
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories (K171307)Endogastric Solutions, Inc.2017-06-22
EsophyX® Z Device with SerosaFuse Fasteners and Accessories (K160960)Endogastric Solutions, Inc.2016-05-01
MUSE System (K151001)Medigus , Ltd.2015-06-05
EsophyX® Z Fastener Delivery Device (K143645)Endogastric Solutions, Inc.2015-03-04
MUSE System (K143634)Medigus , Ltd.2015-01-20
ESOPHYX2 HD (K142113)Endogastric Solutions, Inc.2014-09-30
SRS ENDOSCOPIC STAPLING SYSTEM (K132151)Medigus , Ltd.2014-03-19
SRS ENDOSCOPIC STAPLING SYSTEM (K120299)Medigus , Ltd.2012-05-18
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 (K092400)Endogastric Solutions, Inc.2009-11-06
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT (K072125)Ndo Surgical, Inc.2007-10-18
ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR (K071553)Ndo Surgical, Inc.2007-09-18
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES (K071651)Endogastric Solutions, Inc.2007-09-14
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM (K032820)Ndo Surgical, Inc.2003-10-23
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 (K031262)Ndo Surgical, Inc.2003-05-23
ENDOSCOPIC PLICATION SYSTEM (K023234)Ndo Surgical, Inc.2003-04-17
BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 (K003956)C.R. Bard, Inc.2001-01-05
BARD ENDOSCOPIC SUTURING SYSTEM (K994290)C.R. Bard, Inc.2000-03-20

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Every clearance here is in the API, with alerts when new ones post.