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innolitics.updoc.first_llm_device_clearance.pt

Source: Innolitics regulatory articles (Innolitics) · Innolitics; short quotation · CSV

Innolitics

idtextgradeas of datepublished datetieraudited vs reportedextraction methodreview statusretrieved athttp statuscontent hashsupersedes idurlflags
8da46094b2c903b1K253281 cleared 23 Dec 2025; LLM claim not visible in the public recordgrade B, evidence tier 62025-12-232026-06-256reportedmanualapproved2026-09-10T07:01:53.704032Z200d2eb77b4a1d0source page
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  • 8da46094b2c903b1 FDA's public 510(k) database shows that K253281 cleared on December 23, 2025.