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Clarus Medical, LLC

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
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
510(k) K082038 CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-VBTR2009-04-28 View
510(k) K040919 NUCLEOTOME PROBE SET, MODEL 21200HRX2004-06-01 View
510(k) K040424 LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120GEX2004-05-11 View
510(k) K022610 CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160GEX2002-11-05 View
510(k) K021848 CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160GEX2002-09-03 View
510(k) K011454 SPINE SCOPE, MODEL 2180HRX2001-12-13 View
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