General and Plastic Surgery · 510(k) · 2025
Maestro System (REF100)
Moon Surgical. Cleared by FDA on 14 March 2025 under submission K242323, product code QZB (software controlled endoscope and instrument holder). What FDA's record says, in FDA's words.
Device record · K242323
- Device. Maestro System (REF100)DEVICE
- Company. Moon Surgical (FR)COMPANY
- Decision. 14 March 2025, 510(k), substantially equivalent (traditional review); received 6 August 2024DECISION
- Panel. General and Plastic SurgeryPANEL
- Product code. QZB, Software Controlled Endoscope And Instrument HolderCODE
- Regulation. 21 CFR 876.1500, Class IIREG
- Source. FDA database entry · decision document (13 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 [The Autolap is used] for the purpose of holding and controlling the movement of a standard laparoscope or rigid endoscope for General laparoscopic, Gynecologic and Urologic procedures Substantially equivalent
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.
- Modalities namedendoscopy
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 General and Plastic Surgery, 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.