Home / 510(k) Clearances / K180610

510(k) K180610

Geister retractor for neuro - and spine surgery by Geister Medizin Technik GmbH — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2018
Date Received
March 8, 2018
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 Geister Medizin Technik GmbH

  • K242759 — Geister K-Rex rongeurs (June 6, 2025)
  • K022823 — VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 (July 1, 2004)
  • K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (July 12, 2003)
  • K982365 — ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO V (April 8, 1999)
  • K933699 — GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS (January 27, 1994)

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)
  • 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)