GZT · Retractor, Self-Retaining, For Neurosurgery
Neurology · 21 CFR 882.4800 · Class 2
Overview
| Product Code | GZT |
|---|---|
| Device Name | Retractor, Self-Retaining, For Neurosurgery |
| Regulation | 21 CFR 882.4800 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 43)
Showing 20 most recent of 43 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | Thompson Surgical Instruments, Inc. | May 13, 2022 | SESE |
| K202694 | Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family) | Vycor Medical, Inc. | Jan 14, 2021 | SESE |
| K202072 | MindsEye Expandable Port | Minnetronix Neuro, Inc. | Aug 26, 2020 | SESE |
| K180610 | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | Aug 29, 2018 | SESE |
| K172433 | NICO BrainPath | Nico Corporation | Sep 7, 2017 | SESE |
| K161680 | MEDICON Spinal Spreading Systems | Medicon EG | Mar 24, 2017 | SESE |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | Tedan Surgical Innovations, LLC | Mar 20, 2017 | SESE |
| K161004 | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | Sep 9, 2016 | SESE |
| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | Nico Corporation | Jun 12, 2015 | SESE |
| K120691 | BRAIN PORT | Nico Corporation | Jun 5, 2012 | SESE |
| K113273 | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | Jan 27, 2012 | SESE |
| K112913 | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | Dec 16, 2011 | SESE |
| K093054 | SCALP DURA RETRACTOR, MODEL KS00474 | KARL STORZ Endoscopy-America, Inc. | Nov 15, 2010 | SESE |
| K090272 | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) | Cardinal Health, Inc. | Mar 18, 2009 | SESE |
| K071771 | INSTRUMED RETRACTORS | Instrumed International, Inc. | Aug 2, 2007 | SESE |
| K071338 | FLEX ARM RETRACTOR SYSTEM | Koros USA, Inc. | May 29, 2007 | SESE |
| K062814 | PIPELINE II ACCESS SYSTEM | Depuy Spine, Inc. | Dec 15, 2006 | SESE |
| K060973 | VYCOR SURGICAL ACCESS SYSTEMS | Vycor Medical, LLC | Jul 26, 2006 | SESE |
| K060097 | GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 | KLS-Martin L.P. | Feb 27, 2006 | SESE |
| K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES | Spinal Concepts, Inc. | Apr 15, 2005 | SESE |
Top Applicants
- Nico Corporation — 3 clearances
- Johnson & Johnson — 2 clearances
- Medical Equipment Development Co., Inc. — 2 clearances
- Ohio Medical Instrument Co., Inc. — 2 clearances
- T. Korossurgical Instruments Corp. — 2 clearances
