510(k) Report

FDA applicant

Institut Georges Lopez

Lissieu, FR3 decisions2021–20220 recalls

FDA records 3 decisions for Institut Georges Lopez (Lissieu, FR) from 2021 to 2022: 3 510(k) clearances. Most are in product codes KDL (Set, Perfusion, Kidney, Disposable) and KDN (System, Perfusion, Kidney). Its devices cite 4 predicates, 0 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 Institut Georges Lopez’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2021: 12022: 2
2021high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Institut Georges Lopez by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Institut”

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