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510(k) K153281

BrightMatter Guide with Surface Trace Registration by Synaptive Medical, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2016
Date Received
November 12, 2015
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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  • K180394 — BrightMatter Plan 1.6.0 (March 9, 2018)
  • K160523 — BrightMatter Guide with BrightMatter Pointer (June 24, 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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