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510(k) K250984

Maestro System (REF100) by Moon Surgical — Product Code QZB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 27, 2025
Date Received: March 31, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Software Controlled Endoscope And Instrument Holder
Device Class: Class II
Regulation Number: 876.1500
Review Panel: SU
Submission Type

To hold and position endoscopes and instruments.