Home / 510(k) Clearances / K140705

510(k) K140705

NAVIGABLE BRAIN BIOPSY CANNULA SET by Izi Medical Products — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2014
Date Received
March 21, 2014
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 Izi Medical Products

  • K191012 — Navigated Pedicle Access Kit (August 7, 2019)
  • K162265 — CushionCast Moldable Cushions (November 15, 2016)
  • K143241 — MDT Navigable Brain Biopsy Cannula (April 13, 2015)
  • K142344 — DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System (March 20, 2015)
  • K101373 — EMBRACE (September 15, 2010)

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)