Home / 510(k) Clearances / K092562

510(k) K092562

MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS by FHC, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2009
Date Received
August 20, 2009
Clearance Type
Special
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 FHC, Inc.

  • K231141 — STarFix Designer Software C0265 (September 8, 2023)
  • K200169 — VFS1 Bipolar Electrosurgical Generator (May 14, 2020)
  • K183123 — microTargeting Guideline 4000 5.0 System (December 20, 2018)
  • K121950 — MICROTARGETING XL STAR DRIVE SYSTEM (July 26, 2012)
  • K092192 — WAYPOINT STEREOTACTIC SYSTEM (February 12, 2010)
  • K071364 — MICROTARGETING GUIDELINE 4000 (July 25, 2007)
  • K033173 — MICRO TARGETING ELECTRODE (March 24, 2004)
  • K011775 — MICRO TARGETING DRIVE SYSTEM (August 30, 2001)
  • K011992 — FHC MICROTARGETING DRIVE SYSTEM (August 14, 2001)
  • K003776 — MICROTARGETING DRIVE SYSTEM (February 23, 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)