Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4800](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4800) → GZT — Retractor, Self-Retaining, For Neurosurgery # GZT · Retractor, Self-Retaining, For Neurosurgery _Neurology · 21 CFR 882.4800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT ## Overview - **Product Code:** GZT - **Device Name:** Retractor, Self-Retaining, For Neurosurgery - **Regulation:** [21 CFR 882.4800](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4800) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K210615.md) | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | Thompson Surgical Instruments, Inc. | May 13, 2022 | SESE | | [K202694](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K202694.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K202072.md) | MindsEye Expandable Port | Minnetronix Neuro, Inc. | Aug 26, 2020 | SESE | | [K180610](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K180610.md) | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | Aug 29, 2018 | SESE | | [K172433](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K172433.md) | NICO BrainPath | Nico Corporation | Sep 7, 2017 | SESE | | [K161680](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K161680.md) | MEDICON Spinal Spreading Systems | Medicon EG | Mar 24, 2017 | SESE | | [K161318](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K161318.md) | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | Tedan Surgical Innovations, LLC | Mar 20, 2017 | SESE | | [K161004](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K161004.md) | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | Sep 9, 2016 | SESE | | [K150378](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K150378.md) | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | Nico Corporation | Jun 12, 2015 | SESE | | [K120691](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K120691.md) | BRAIN PORT | Nico Corporation | Jun 5, 2012 | SESE | | [K113273](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K113273.md) | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | Jan 27, 2012 | SESE | | [K112913](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K112913.md) | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | Dec 16, 2011 | SESE | | [K093054](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K093054.md) | SCALP DURA RETRACTOR, MODEL KS00474 | KARL STORZ Endoscopy-America, Inc. | Nov 15, 2010 | SESE | | [K090272](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K090272.md) | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) | Cardinal Health, Inc. | Mar 18, 2009 | SESE | | [K071771](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K071771.md) | INSTRUMED RETRACTORS | Instrumed International, Inc. | Aug 2, 2007 | SESE | | [K071338](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K071338.md) | FLEX ARM RETRACTOR SYSTEM | Koros USA, Inc. | May 29, 2007 | SESE | | [K062814](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K062814.md) | PIPELINE II ACCESS SYSTEM | Depuy Spine, Inc. | Dec 15, 2006 | SESE | | [K060973](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K060973.md) | VYCOR SURGICAL ACCESS SYSTEMS | Vycor Medical, LLC | Jul 26, 2006 | SESE | | [K060097](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K060097.md) | GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 | KLS-Martin L.P. | Feb 27, 2006 | SESE | | [K050706](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K050706.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com