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Clarus Medical, LLC

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2026-05-26
TypeNumberDevice NameCodeDateActions
510(k) K252790 Digital ClarusScope System and Digital NeuroPEN SystemHRX2026-05-26 View
510(k) K240535 Digital ClarusScope System; Digital NeuroPEN SystemHRX2024-04-25 View
510(k) K223615 Digital ClarusScope System, Digital NeuroPEN SystemGWG2023-11-21 View
510(k) K200925 Clarus Peel-Away Introducer SheathGWG2021-03-18 View