FDA 483 - Moon Surgical

This document is a 510(k) submission (K242323) from Moon Surgical for their Maestro System, a device intended to hold and position laparoscopic instruments during surgical procedures, including a new ScoPilot feature. The FDA has reviewed the submission and identified both major and minor deficiencies, requiring additional information before clearance can be granted. The submission is currently on hold pending a complete response from Moon Surgical.