K221410 is an FDA 510(k) clearance for the Maestro Platform. This device is classified as a Table, Operating-room, Ac-powered (Class I - General Controls, product code FQO).
Submitted by Moon Surgical (Paris, FR). The FDA issued a Cleared decision on December 2, 2022, 200 days after receiving the submission on May 16, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K221410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2022 |
| Decision Date | December 02, 2022 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FQO - Table, Operating-room, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |