Devices · Moon Surgical

Maestro System (REF100)

Moon Surgical is listed for Maestro System (REF100) (K250984). The FDA list gives June 27, 2025 as the date of the final decision. The lead panel is Gastroenterology-Urology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QZB as “Software Controlled Endoscope And Instrument Holder”: To hold and position endoscopes and instruments. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250984

Official FDA database record

Date of final decision

June 27, 2025

Company on the FDA list

Moon Surgical

Lead panel

Gastroenterology-Urology

Primary product code

QZB

openFDA device name for the code

Software Controlled Endoscope And Instrument Holder

Device class

2

Regulation number

876.1500

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary