Cleared Traditional

K250984 - Maestro System (REF100) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250984 · Moon Surgical · General & Plastic Surgery device
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Jun 2025
Decision
88d
Days
Class 2
Risk

K250984 is an FDA 510(k) clearance for the Maestro System (REF100). Classified as Software Controlled Endoscope And Instrument Holder (product code QZB), Class II - Special Controls.

Submitted by Moon Surgical (Paris, FR). The FDA issued a Cleared decision on June 27, 2025 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K250984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2025
Decision Date June 27, 2025
Days to Decision 88 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 Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 114d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code QZB Software Controlled Endoscope And Instrument Holder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold And Position Endoscopes And Instruments.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.