Company profile

Moon Surgical

Moon Surgical has 2 AI-enabled medical devices on the FDA list. The first decision was on March 14, 2025 and the most recent on June 27, 2025 (Maestro System (REF100)). Its most common review panel is Gastroenterology-Urology (1 device).

2AI devices

2025First decision

2025Latest decision

2Specialties

Timeline

June 27, 2025 · 510(k) K250984Maestro System (REF100) · Gastroenterology-Urology · QZB
March 14, 2025 · 510(k) K242323Maestro System (REF100) · General and Plastic Surgery · QZB