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510(k) K172433

NICO BrainPath by Nico Corporation — Product Code GZT

K172433 is an FDA 510(k) premarket notification submitted by Nico Corporation for the device "NICO BrainPath". The FDA issued a decision of Substantially Equivalent on September 7, 2017. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Nico Corporation has at least 8 other 510(k) clearances on record.

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

  • K232567 — Myriad SPECTRA Light Source (March 14, 2024)
  • K191599 — NICO Myriad NOVUS (September 13, 2019)
  • K182340 — NICO Myriad (September 20, 2018)
  • 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)

FDA data resources