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510(k) K060973

VYCOR SURGICAL ACCESS SYSTEMS by Vycor Medical, LLC — Product Code GZT

K060973 is an FDA 510(k) premarket notification submitted by Vycor Medical, LLC for the device "VYCOR SURGICAL ACCESS SYSTEMS". The FDA issued a decision of Substantially Equivalent on Jul 26, 2006. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Vycor Medical, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 26, 2006
Date Received
Apr 10, 2006
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 by Vycor Medical, LLC

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

Other clearances for product code GZT

  • K252995 — Durashield Device Kit (Sep 17, 2026)
  • 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 (Jan 14, 2021)
  • K202072 — MindsEye Expandable Port (Aug 26, 2020)
  • K180610 — Geister retractor for neuro - and spine surgery (Aug 29, 2018)
  • K172433 — NICO BrainPath (Sep 7, 2017)
  • K161680 — MEDICON Spinal Spreading Systems (Mar 24, 2017)
  • K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological (Mar 20, 2017)
  • K161004 — Self-retaining Retractor (Sep 9, 2016)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (Jun 12, 2015)

FDA data resources