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510(k) K202072

MindsEye Expandable Port by Minnetronix Neuro, Inc. — Product Code GZT

K202072 is an FDA 510(k) premarket notification submitted by Minnetronix Neuro, Inc. for the device "MindsEye Expandable Port". The FDA issued a decision of Substantially Equivalent on August 26, 2020. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2020
Date Received
July 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances for product code GZT

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  • K202694 — Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (January 14, 2021)
  • 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)
  • 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