Home / 510(k) Clearances / K011775

510(k) K011775

MICRO TARGETING DRIVE SYSTEM by FHC, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2001
Date Received
June 7, 2001
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 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)
  • K092562 — MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS (September 18, 2009)
  • K071364 — MICROTARGETING GUIDELINE 4000 (July 25, 2007)
  • K033173 — MICRO TARGETING ELECTRODE (March 24, 2004)
  • 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)