Cleared Traditional

K221410 - Maestro Platform (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K221410 · Moon Surgical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
200d
Days
Class 1
Risk

K221410 is an FDA 510(k) clearance for the Maestro Platform. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Moon Surgical (Paris, FR). The FDA issued a Cleared decision on December 2, 2022 after a review of 200 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Moon Surgical devices

Submission Details

510(k) Number K221410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 114d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQO Table, Operating-room, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Daniel & Daniel Consulting
Michael Daniel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.