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Data / Medical devices / United States / Moon Surgical, Inc.

Moon Surgical, Inc.: FDA-registered device maker in San Carlos, CA, United States, 3 510(k) clearances

Moon Surgical, Inc. is registered with the FDA (registration 3026790309) in San Carlos, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 27, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3026790309
Address
619 Old County Road, San Carlos, CA, United States, 94070
Owner or operator
Moon Surgical SAS (10087598)
Roles
Manufacturer
First device listed
August 30, 2024
Registered through
2026
Brand names listed
Maestro System, Maestro system

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 27, 2025K250984Maestro System (REF100)QZBSubstantially EquivalentMoon Surgicalaccessdata.fda.gov
March 14, 2025K242323Maestro System (REF100)QZBSubstantially EquivalentMoon Surgicalaccessdata.fda.gov
June 3, 2024K240598Maestro System (REF100)FQOSubstantially EquivalentMoon Surgicalaccessdata.fda.gov

Compare with other makers

Updated June 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.