Maestro Platform— 510(k) K221410

Name: FDA 510(k) clearance K221410
Creator: U.S. Food and Drug Administration
Published: 2022-12-02

Substantially Equivalent

Moon Surgical

FDA 510(k) clearance K221410 for Maestro Platform, Substantially Equivalent on 2022-12-02. 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: 2022-05-16
Decision date: 2022-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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K972810 — OPT80 THE TRANSPORTABLE (OPT80)1997-08-26
K971988 — ALLEN, ULTRA AND SMART SOCKETS1997-07-11
K971307 — AMSCO SURGICAL TABLE1997-06-27

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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.