Home / 510(k) Clearances / K142024

510(k) K142024

BRIGHTMATTER NAVIGATION SYSTEM by Synaptive Medical, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2015
Date Received
July 25, 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 Synaptive Medical, Inc.

  • K231986 — Modus IR (March 25, 2024)
  • K232981 — Synq Software Version 1.3 (October 11, 2023)
  • K200327 — Evry (April 29, 2020)
  • K183325 — Modus Nav (July 14, 2019)
  • K180394 — BrightMatter Plan 1.6.0 (March 9, 2018)
  • K160523 — BrightMatter Guide with BrightMatter Pointer (June 24, 2016)
  • K153281 — BrightMatter Guide with Surface Trace Registration (March 30, 2016)
  • K153284 — Synaptive ImageDrive Pro (March 29, 2016)
  • K140337 — BRIGHTMATTER PLANNING SOFTWARE (June 2, 2014)

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)