Hardware PCCPs
6 of the 176 FDA-authorized PCCPs are Hardware plans. Here is the full list, newest first.
- K253527Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)Covidien, LLC2026-07-01Non-AIHardware
- K261021EasyWhip FamilyWinter Innovations, Inc.2026-07-01Non-AIHardware
- K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.2026-06-12Non-AIHardware
- K260212EnSite X EP SystemABBOTT MEDICAL2026-04-20AI hardwareHardware
- K251519RelieVRx (Pico G3)Appliedvr2025-08-13Non-AIHardware
- K243999TriMed Ankle Fixation SystemTriMed, Inc.2025-03-19Non-AIHardware
Other PCCP types
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We read the Hardware 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.