Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Moon Surgical. It received FDA 510(k) clearance on 2025-06-27 under 510(k) 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. The listed applicant is Moon Surgical. The 510(k) number is K250984.

When did Maestro System (REF100) receive FDA 510(k) clearance?

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

Who is the listed applicant for Maestro System (REF100)?

The FDA 510(k) record lists Moon Surgical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Moon Surgical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: QZB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261573ENDOSCOPE HOLDER (182214)Aktormed GmbHK242323Maestro System (REF100)Moon SurgicalK233312SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894Aktormed GmbH

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.

↑