GZT — Retractor, Self-Retaining, For Neurosurgery Class II
FDA product code GZT covers "Retractor, Self-Retaining, For Neurosurgery", a Class II medical device regulated under 21 CFR 882.4800. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GZT
- Device Class
- Class II
- Regulation Number
- 882.4800
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252995 | Surgentec | Durashield Device Kit | Sep 17, 2026 |
| K210615 | Thompson Surgical Instruments | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clam | May 13, 2022 |
| K202694 | Vycor Medical | Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip | Jan 14, 2021 |
| K202072 | Minnetronix Neuro | MindsEye Expandable Port | Aug 26, 2020 |
| K180610 | Geister Medizin Technik | Geister retractor for neuro - and spine surgery | Aug 29, 2018 |
| K172433 | Nico Corporation | NICO BrainPath | Sep 7, 2017 |
| K161680 | Medicon Eg | MEDICON Spinal Spreading Systems | Mar 24, 2017 |
| K161318 | Tedan Surgical Innovations | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological | Mar 20, 2017 |
| K161004 | Fetzer Medical Gmbh And Co. Kg | Self-retaining Retractor | Sep 9, 2016 |
| K150378 | Nico Corporation | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | Jun 12, 2015 |
| K120691 | Nico Corporation | BRAIN PORT | Jun 5, 2012 |
| K113273 | Johnson And Johnson | SPOTLIGHT ACCESS SYSTEM | Jan 27, 2012 |
| K112913 | Johnson And Johnson | SPOTLIGHT ACCESS SYSTEM | Dec 16, 2011 |
| K093054 | Karl Storz Endoscopy-America | SCALP DURA RETRACTOR, MODEL KS00474 | Nov 15, 2010 |
| K090272 | Cardinal Health | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) | Mar 18, 2009 |
| K071771 | Instrumed International | INSTRUMED RETRACTORS | Aug 2, 2007 |
| K071338 | Koros Usa | FLEX ARM RETRACTOR SYSTEM | May 29, 2007 |
| K062814 | Depuy Spine | PIPELINE II ACCESS SYSTEM | Dec 15, 2006 |
| K060973 | Vycor Medical | VYCOR SURGICAL ACCESS SYSTEMS | Jul 26, 2006 |
| K060097 | Kls-Martin L.P | GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 | Feb 27, 2006 |