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510(k) K160523

BrightMatter Guide with BrightMatter Pointer by Synaptive Medical, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2016
Date Received
February 25, 2016
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.

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  • 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)
  • K153281 — BrightMatter Guide with Surface Trace Registration (March 30, 2016)
  • K153284 — Synaptive ImageDrive Pro (March 29, 2016)
  • K142024 — BRIGHTMATTER NAVIGATION SYSTEM (April 2, 2015)
  • K140337 — BRIGHTMATTER PLANNING SOFTWARE (June 2, 2014)

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