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510(k) K024201

NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 by Image-Guided Neurologics, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2003
Date Received
December 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Image-Guided Neurologics, Inc.

  • K050772 — NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 (April 21, 2005)
  • K043091 — NAVIGUS NEXDRIVE, MODEL MI-3000 (February 7, 2005)
  • K040334 — NAVIGUS PASSIVE PROBE, MODEL NP-1000 (October 4, 2004)
  • K040834 — NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 (June 3, 2004)
  • K033619 — NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 (March 2, 2004)
  • K031885 — NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX (August 21, 2003)
  • K023949 — NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES (February 25, 2003)
  • K022100 — NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1 (September 25, 2002)
  • K012719 — NAVIGUS II MR (October 22, 2001)
  • K012366 — NAVIGUS II TRAJECTORY GUIDE (October 1, 2001)

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