Gastroenterology, Urology PCCPs
4 of the 155 FDA-authorized PCCPs are in the Gastroenterology, Urology panel, 1 of them AI/SaMD. Here is the full list, newest first.
- K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation2026-06-24Non-AICompatibility expansion
- K253984Instrument Exit Point on Touch Surgery AideCovidien, LLC2026-06-04AI/SaMDUnknown
- K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG2025-12-18Non-AIOther
- K250984Maestro System (REF100)Moon Surgical2025-06-27AI hardwareRetraining
Other panels
Want the monitoring teardown?
We read the Gastroenterology, Urology PCCPs in this list, 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.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.