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SerosaFuse Implantable Fasteners, Associated Delivery Devices and Accessories

by Endogastric Solutions, Inc. United States(FDA 510(k) applicant) 510(k)

510(k) K071651 Product code ODE

Overview

The SerosaFuse Implantable Fasteners, Associated Delivery Devices and Accessories is an Endoscopic Suture/Plication System designed for transoral, endoluminal tissue approximation. These devices are intended for full-thickness tissue fastening, typically used in procedures addressing gastroesophageal reflux disease (GERD) by securing tissue layers together. The system includes implantable fasteners and delivery tools to facilitate precise placement under endoscopic guidance.

The system is supplied as a sterile, single-use device, comprising cartridges of 7.5mm fasteners (20 per cartridge) and an EsophyX Fastener Delivery Device. It is classified as a Class II medical device under FDA regulations (876.1500) and has received FDA 510K clearance for use in gastroenterology and urology procedures. Storage and handling must comply with sterile medical device protocols to ensure integrity before use.

Summary written by AI from registry data, 19 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071651 Date14 Sep 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
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United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

Full name
Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories
510(k) Number
FDA Product Code
ODE
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K071651 24 fields · synced 6 Oct 2026