Home / 510(k) Clearances / K001192

510(k) K001192

SELF ADHERING NAVIGUS GUIDE by Image-Guided Neurologics, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2000
Date Received
April 12, 2000
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)
  • K024201 — NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 (March 12, 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)

Other clearances for product code HAW

  • K231897 — NeuroAlign software (October 21, 2025)
  • K251317 — SOLOPASS 2.0 System (September 5, 2025)
  • K250893 — Ball Joint Guide Array (66295) (September 4, 2025)
  • K250505 — EZ-FIDUCIALS (July 9, 2025)
  • K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S (May 23, 2025)
  • K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial (February 5, 2025)
  • K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm (January 28, 2025)
  • K243657 — ClearPoint System (Software Version 3.0) (January 24, 2025)
  • K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) (January 17, 2025)
  • K242480 — FLASH EVD System (10-0002) (December 27, 2024)