510(k) Report

FDA applicant

Luneau Gynecologie SA

Chartres Cedex, FR1 decision2000–20000 recalls

FDA records 1 decision for Luneau Gynecologie SA (Chartres Cedex, FR) in 2000: 1 510(k) clearance. All are in product code KNC (Table, Obstetric (And Accessories)). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Luneau Gynecologie SA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Luneau Gynecologie SA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Luneau Gynecologie SA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Luneau”

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