Maestro System (REF100)— 510(k) K240598

Name: FDA 510(k) clearance K240598
Creator: U.S. Food and Drug Administration
Published: 2024-06-03

Substantially Equivalent

Moon Surgical

FDA 510(k) clearance K240598 for Maestro System (REF100), Substantially Equivalent on 2024-06-03. Applicant: Moon Surgical. Device class: 1.

Clearance details

Applicant: Moon Surgical
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 2024-03-04
Decision date: 2024-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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K250984 — Maestro System (REF100)2025-06-27
K242323 — Maestro System (REF100)2025-03-14

Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.