Gastroenterology-Urology · 510(k) · 2025
Maestro System (REF100)
Moon Surgical. Cleared by FDA on 27 June 2025 under submission K250984, product code QZB (software controlled endoscope and instrument holder). What FDA's record says, in FDA's words.
Device record · K250984
- Device. Maestro System (REF100)DEVICE
- Company. Moon Surgical (FR)COMPANY
- Decision. 27 June 2025, 510(k), substantially equivalent (traditional review); received 31 March 2025DECISION
- Panel. Gastroenterology-UrologyPANEL
- Product code. QZB, Software Controlled Endoscope And Instrument HolderCODE
- Regulation. 21 CFR 876.1500, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Maestro System is intended to hold and position laparoscopic Instruments during laparoscopic surgical procedures. Same Identical System basic components Two motorized Arms that hold and position the laparoscope and/or laparoscopic instruments Two stages, supporting and positioning the arms A Control Unit that controls the movements of the arms Instrument Coupling Same Identical Maestro System – Connectivity – 510(k) submission June 26 th, 2025 Moon Surgical Daniel & Daniel Consulting, LLC ASPECT MOON SURGICAL (Subject Device) MOON SURGICAL (Predicate Device)
The product code's definition, from FDA's classification record. To hold and position endoscopes and instruments.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QZB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QZB, in Gastroenterology-Urology, from Moon Surgical, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.