Compass(Tm) Stereotactic Retractor System

FDA 510(k) K896156 · Stereotactic Medical Systems, Inc.

Substantially Equivalent

510(k) numberK896156

Submission

Device name
Compass(Tm) Stereotactic Retractor System
Applicant
Stereotactic Medical Systems, Inc.
New Harford, NY, US
Received
October 24, 1989
Decision date
December 6, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GZT – Retractor, Self-Retaining, For Neurosurgery
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4800
Specialty
Neurology

Other 510(k)s with product code GZT

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K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS…GZT · Traditional Vycor Medical, Inc.01/14/2021SE
K202072MindsEye Expandable PortGZT · Traditional Minnetronix Neuro, Inc.08/26/2020SE
K180610Geister retractor for neuro - and spine surgeryGZT · Traditional Geister Medizin Technik GmbH08/29/2018SE
K172433NICO BrainPathGZT · Special Nico Corporation09/07/2017SE
K161680MEDICON Spinal Spreading SystemsGZT · Traditional Medicon EG03/24/2017SE
K161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional Tedan Surgical Innovations, LLC03/20/2017SE
K161004Self-retaining RetractorGZT · Traditional Fetzer Medical GmbH & Co. KG09/09/2016SE
K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookGZT · Traditional Nico Corporation06/12/2015SE
K120691Brain PortGZT · Traditional Nico Corporation06/05/2012SE

More from Nico Corporation

510(k)DeviceDecision
K884415EP-100 (Series)FPD · Traditional 02/28/1989SE
K883653EP-100 Infusion PumpFRN · Traditional 11/01/1988SE
K871046Compass Stereotactic Positioning SystemHAW · Traditional 05/08/1987SE
K862220Compass CT Stereotactic Adaptation SystemHAW · Traditional 06/18/1986SE

Questions and answers

When was Compass(Tm) Stereotactic Retractor System cleared by the FDA?

Compass(Tm) Stereotactic Retractor System (K896156) received a 510(k) decision of Substantially Equivalent on December 6, 1989, 43 days after the submission was received.

What is the product code of K896156?

The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.