Maestro System (REF100)
Moon Surgical · K250984
FDA-authorized Predetermined Change Control Plan
- Company
- Moon Surgical
- 510(k)/De Novo #
- K250984
- Decision date
- 2025-06-27
- Panel
- Gastroenterology, Urology
- Pathway
- 510(k)
- Category
- AI hardware
- PCCP type
- Retraining
- Monitoring commitment
- Not stated
What this PCCP covers. Permits model retraining with additional data
Other Gastroenterology, Urology PCCPs
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We read the PCCP for Maestro System (REF100), then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
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