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EsophyX Z+ Device with SerosaFuse Fasteners and Accessories

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

510(k) K240879 Product code ODE

Regulatory status

as of 26 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK240879 Date26 Apr 2024ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1640-2025 FDA Class II initiated 14 Mar 2025
    • Ongoing Z-1641-2025 FDA Class II initiated 14 Mar 2025

    Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Specification

510(k) · synced 10 Oct 2026

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

Other devices from Endogastric Solutions, Inc.

See all devices from Endogastric Solutions, Inc. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K240879 24 fields · synced 10 Oct 2026