# FDA 483 - Moon Surgical - Unknown Date

Source: https://www.keypedia.com/records/483/moon-surgical/1f28961c-8384-4f2c-80a6-a11b92a16034

> FDA 483 for Moon Surgical on Unknown Date. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Moon Surgical
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

Company: https://www.keypedia.com/companies/moon-surgical/66e7ea92-ac87-4795-8574-e0b95390f0e9

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4