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510(k) K150378

NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook by Nico Corporation — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2015
Date Received
February 13, 2015
Clearance Type
Traditional
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

  • K232567 — Myriad SPECTRA Light Source (March 14, 2024)
  • K191599 — NICO Myriad NOVUS (September 13, 2019)
  • K182340 — NICO Myriad (September 20, 2018)
  • K172433 — NICO BrainPath (September 7, 2017)
  • K161307 — NICO Myriad (December 21, 2016)
  • K162075 — NICO TRIOwand (August 11, 2016)
  • 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)
  • K172433 — NICO BrainPath (September 7, 2017)
  • 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)
  • K120691 — BRAIN PORT (June 5, 2012)
  • K113273 — SPOTLIGHT ACCESS SYSTEM (January 27, 2012)