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510(k) K902517

NEUROSURGICAL HEADFRAME ACCESSORIES by Sims Surgical, Inc. — Product Code GZT

K902517 is an FDA 510(k) premarket notification submitted by Sims Surgical, Inc. for the device "NEUROSURGICAL HEADFRAME ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 3, 1990. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Sims Surgical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1990
Date Received
June 7, 1990
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 Sims Surgical, Inc.

  • K902180 — TRACHEAL TUBE STYLET (July 19, 1990)
  • K902516 — NEW LENGTH SUGITA APPLIERS (July 3, 1990)

Other clearances for product code GZT

  • K252995 — Durashield Device Kit (September 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 (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)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (June 12, 2015)

FDA data resources