510(k) Report

FDA applicant

Moon Surgical

Paris, FR4 decisions2022–20250 recalls

FDA records 4 decisions for Moon Surgical (Paris, FR) from 2022 to 2025: 4 510(k) clearances. Most are in product codes QZB (Software Controlled Endoscope And Instrument…) and FQO (Table, Operating-Room, Ac-Powered). Its devices cite 6 predicates, 4 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 Moon Surgical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2022: 12024: 12025: 2
2022high 2 (2025) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Moon Surgical by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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