OTSCneo System Set (100.03n-14n, 100.27n-31n)
Ovesco Endoscopy AG · K251562
FDA-authorized Predetermined Change Control Plan
- Company
- Ovesco Endoscopy AG
- 510(k)/De Novo #
- K251562
- Decision date
- 2025-12-18
- Panel
- Gastroenterology, Urology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Other
- Monitoring commitment
- Not stated
What this PCCP covers. Permits defined post-clearance changes
Other Gastroenterology, Urology PCCPs
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We read the PCCP for OTSCneo System Set (100.03n-14n, 100.27n-31n), 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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