Cleared Traditional

K240598 - Maestro System (REF100)

K240598 is an FDA 510(k) clearance for Maestro System (REF100), manufactured by Moon Surgical. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K240598 · Moon Surgical · General & Plastic Surgery device
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Jun 2024
Decision
91d
Days
Class 1
Risk

K240598 is an FDA 510(k) clearance for the Maestro System (REF100). 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 June 3, 2024 after a review of 91 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K240598

510(k) Number K240598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2024
Decision Date June 03, 2024
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

FQO Device Classification - Class 1, General Controls

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.

Regulatory Peers - FQO Table, Operating-room, Ac-powered

All 7
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K240598.
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712 PLASTIC SURGERY TABLE & ACCESORIES
K915141 · Midmark Corp. · Jan 1992