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510(k) K172433

NICO BrainPath by Nico Corporation — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2017
Date Received
August 11, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

Other clearances by Nico Corporation

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  • K161307 — NICO Myriad (December 21, 2016)
  • K162075 — NICO TRIOwand (August 11, 2016)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (June 12, 2015)
  • K150993 — NICO TRIOwand (April 23, 2015)
  • K120691 — BRAIN PORT (June 5, 2012)

Other clearances for product code GZT

  • K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clam (May 13, 2022)
  • K202694 — Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (January 14, 2021)
  • K202072 — MindsEye Expandable Port (August 26, 2020)
  • K180610 — Geister retractor for neuro - and spine surgery (August 29, 2018)
  • K161680 — MEDICON Spinal Spreading Systems (March 24, 2017)
  • K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological (March 20, 2017)
  • K161004 — Self-retaining Retractor (September 9, 2016)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (June 12, 2015)
  • K120691 — BRAIN PORT (June 5, 2012)
  • K113273 — SPOTLIGHT ACCESS SYSTEM (January 27, 2012)