FDA applicant

Endo Tools Therapeutics S.A.

Charleroi, BE2 decisions2021–20260 recalls

FDA records 2 decisions for Endo Tools Therapeutics S.A. (Charleroi, BE) from 2021 to 2026: 2 510(k) clearances. All are in product code OCW (Endoscopic Tissue Approximation Device). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Endo Tools Therapeutics S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Endo Tools Therapeutics S.A. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Endo Tools Therapeutics S.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Endo”

FDA records each applicant name separately; these may or may not be the same firm.

Endo Lase, Inc. 24 Endo Technic Corp. 10 Endo-Therapeutics, Inc. 7 Endo GI Medical 2 Endo Surgical Concepts, Inc. 2 Endo Twinn B.V. 2 Endo Surgical Devices, Inc. 2 Endo Optics, Inc. 2 Endo-Scientific, Inc. 2 Endo Vantage, LLC 1 Endo-Aid, Inc. 1 Endo Smart Cap Co. 1

Endo Tools Therapeutics S.A.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Endo”