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FDA 510(k)

Maestro System (REF100)

K-Number: K250984 · 2025-06-27

ApplicantMoon Surgical
Decision Date2025-06-27
Product CodeQZB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Maestro System (REF100) is a medical device manufactured by Moon Surgical. It received FDA 510(k) clearance on 2025-06-27 under approval number K250984. The device is classified under product code QZB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maestro System (REF100)?

Maestro System (REF100) is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Moon Surgical. The 510(k) number is K250984.

When was Maestro System (REF100) approved by the FDA?

Maestro System (REF100) received FDA 510(k) clearance on 2025-06-27, under approval number K250984.

What company makes Maestro System (REF100)?

Maestro System (REF100) is manufactured by Moon Surgical.

What is the FDA product code for Maestro System (REF100)?

The FDA product code for Maestro System (REF100) is QZB.

Other Devices by Moon Surgical

K221410Maestro Platform K240598Maestro System (REF100) K242323Maestro System (REF100)

Related Devices (Code: QZB)

K233312SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894Aktormed GmbH K242323Maestro System (REF100)Moon Surgical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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