Obstetrics/Gynecology PCCPs
4 of the 176 FDA-authorized PCCPs are in the Obstetrics/Gynecology panel, 1 of them AI/SaMD. Here is the full list, newest first.
- K253694Natural CyclesNatural Cycles Nordic AB2026-07-17AI/SaMDCompatibility expansion
- K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.2025-04-02Non-AIUnknown
- K241368Sonicaid Team3Huntleigh Healthcare , Ltd.2025-02-03AI hardwareUnknown
- K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation2025-01-13Non-AIUnknown
Other panels
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We read the Obstetrics/Gynecology 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.