Cleared Traditional

Maestro Platform

K221410 · Moon Surgical · General & Plastic Surgery
Dec 2022
Decision
200d
Days
Class 1
Risk

About This 510(k) Submission

K221410 is an FDA 510(k) clearance for the Maestro Platform, a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by Moon Surgical (Paris, FR). The FDA issued a Cleared decision on December 2, 2022, 200 days after receiving the submission on May 16, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K221410 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2022
Decision Date December 02, 2022
Days to Decision 200 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FQO — Table, Operating-room, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960