Cleared Traditional

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

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

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

Submitted by Moon Surgical (Paris, FR). The FDA issued a Cleared decision on June 27, 2025, 88 days after receiving the submission on March 31, 2025.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Hold And Position Endoscopes And Instruments..

Submission Details

510(k) Number K250984 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code QZB — Software Controlled Endoscope And Instrument Holder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold And Position Endoscopes And Instruments.