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Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

FDA product code ODE · Class 2 · Gastroenterology, Urology

14
Registered devices
359
Adverse events
4
Recalls
20
510(k) clearances

Devices with this code

EsophyX2 HD — ENDOGASTRIC SOLUTIONS, INC.SerosaFuse® — Merit Medical Systems, Inc.SerosaFuse® Implantable Fastener Kit — ENDOGASTRIC SOLUTIONS, INC.SerosaFuse® — Merit Medical Systems, Inc.7.5mm Cartridge — ENDOGASTRIC SOLUTIONS, INC.EsophyX Z — ENDOGASTRIC SOLUTIONS, INC.6.5mm & 7.5mm Cartridge — ENDOGASTRIC SOLUTIONS, INC.EsophyX Z+ — ENDOGASTRIC SOLUTIONS, INC.MUSE Endostapler — MEDIGUS LTDSerosaFuse® 7.5mm Implantable Fastener Cartridges — ENDOGASTRIC SOLUTIONS, INC.MUSE Console — MEDIGUS LTDEsophyX® Z+ — Merit Medical Systems, Inc.MUSE Staple Cartridge — MEDIGUS LTD6.5mm Cartridge — ENDOGASTRIC SOLUTIONS, INC.

Recent recalls

DateFirmReason
2025-03-14Merit Medical Systems, Inc.Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
2025-03-14Merit Medical Systems, Inc.Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
2013-06-06Endogastric Solutions IncEndogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 devi
2013-02-04Endogastric Solutions IncEsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.