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Image-Guided Neurologics, Inc.

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K050772 NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000HAW2005-04-21 View
510(k) K043091 NAVIGUS NEXDRIVE, MODEL MI-3000HAW2005-02-07 View
510(k) K040334 NAVIGUS PASSIVE PROBE, MODEL NP-1000HAW2004-10-04 View
510(k) K040834 NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000HAW2004-06-03 View
510(k) K033619 NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000HAW2004-03-02 View
510(k) K031885 NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXXHBL2003-08-21 View
510(k) K024201 NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000HAW2003-03-12 View
510(k) K023949 NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULESHAW2003-02-25 View
510(k) K022100 NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010HAW2002-09-25 View
510(k) K012719 NAVIGUS II MRHAW2001-10-22 View
510(k) K012366 NAVIGUS II TRAJECTORY GUIDEHAW2001-10-01 View
510(k) K011971 NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000HAW2001-08-03 View
510(k) K001097 ACTIVE ARRAY CATHETER, MODEL CS-2000MOS2001-01-18 View
510(k) K001096 BURR HOLE COVER, MODEL XXGXR2000-10-25 View
510(k) K002330 NAVIGUS PEEL AWAY INTRODUCERGWG2000-10-18 View
510(k) K001192 SELF ADHERING NAVIGUS GUIDEHAW2000-06-07 View
510(k) K000195 CRANIAL DRILLHBB2000-04-20 View
510(k) K993682 MRI EQUIPMENT COVERLNH2000-01-20 View
510(k) K992796 ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000HCA1999-10-25 View
510(k) K992304 NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXXHAW1999-08-27 View
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