Other PCCPs
9 of the 143 FDA-authorized PCCPs are Other plans, 1 of them AI/SaMD. Here is the full list, newest first.
- K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)Yadu Medical (Henan) Co., Ltd.2026-02-04Non-AIOther
- K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC2026-01-09Non-AIOther
- K253281UpDocUpdoc, Inc.2025-12-23AI/SaMDOther
- K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG2025-12-18Non-AIOther
- K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC2025-10-10Non-AIOther
- K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)Vitacore Industries, Inc.2025-09-17Non-AIOther
- K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and Company2025-08-08Non-AIOther
- K250447BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company2025-05-19Non-AIOther
- K243943TriMed® Compression ScrewsTriMed, Inc.2025-04-10Non-AIOther
Other PCCP types
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We read the Other 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.