K250984 is an FDA 510(k) clearance for the Maestro System (REF100). This device is classified as a Software Controlled Endoscope And Instrument Holder (Class II - Special Controls, product code QZB).
Submitted by Moon Surgical (Paris, FR). The FDA issued a Cleared decision on June 27, 2025, 88 days after receiving the submission on March 31, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Hold And Position Endoscopes And Instruments..
| 510(k) Number | K250984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2025 |
| Decision Date | June 27, 2025 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QZB - Software Controlled Endoscope And Instrument Holder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Hold And Position Endoscopes And Instruments. |