Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Moon Surgical with 4 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Jun 27, 2025: Maestro System (REF100).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 27, 2025 | Maestro System (REF100)K250984 · QZB | 510(k) clearances |
| Jun 27, 2025 | Maestro System (REF100)K250984 · Gastroenterology-Urology | AI-enabled devices |
| Mar 14, 2025 | Maestro System (REF100)K242323 · QZB | 510(k) clearances |
| Mar 14, 2025 | Maestro System (REF100)K242323 · General and Plastic Surgery | AI-enabled devices |
| Jun 3, 2024 | Maestro System (REF100)K240598 · FQO | 510(k) clearances |
| Dec 2, 2022 | Maestro PlatformK221410 · FQO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
