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510(k) K253379

Stealth AXiS Cranial clinical application by Medtronic Navigation, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2026
Date Received
September 30, 2025
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 Medtronic Navigation, Inc.

  • K253395 — Stealth AXiS™ ENT clinical application (March 16, 2026)
  • K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Appli (March 13, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K251282 — StealthStation S8 Spine Software (October 17, 2025)
  • K242464 — Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (June 5, 2025)
  • K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422) (May 29, 2025)
  • K240465 — O-arm O2 Imaging System (June 21, 2024)
  • K231976 — StealthStation Cranial Software, v3.1.5 (9735585) (October 19, 2023)
  • K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 (June 10, 2022)
  • K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4) (January 7, 2022)

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)