Retractor, Self-Retaining, For Neurosurgery
FDA product code GZT · Class II (moderate risk) · 21 CFR 882.4800 · Neurology
43510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Nico Corporation 3
- Vycor Medical, Inc. 2
- Ohio Medical Instrument Co., Inc. 2
- Johnson & Johnson 2
- Medical Equipment Development Co., Inc. 2
- T. Korossurgical Instruments Corp. 2
- Stereotactic Medical Systems, Inc. 1
- V. Mueller Neuro/Spine 1
- Hamid M. Mehdizadeh, M.D. 1
- Codman & Shurtleff, Inc. 1
- International Hospital Supply Co. 1
- A. Henniss 1
- Sims Surgical, Inc. 1
- Electrical Systems Div. 1
- Cimarron Instruments, Inc. 1
- Thompson Surgical Instruments, Inc. 1
- Zinnanti Surgical Instruments, Inc. 1
- Karlin Technology, Inc. 1
- Solway, Inc. 1
- Cedar Surgical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp…GZT · Traditional | Thompson Surgical Instruments, Inc. | 05/13/2022SE |
| K202694 | Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS…GZT · Traditional | Vycor Medical, Inc. | 01/14/2021SE |
| K202072 | MindsEye Expandable PortGZT · Traditional | Minnetronix Neuro, Inc. | 08/26/2020SE |
| K180610 | Geister retractor for neuro - and spine surgeryGZT · Traditional | Geister Medizin Technik GmbH | 08/29/2018SE |
| K172433 | NICO BrainPathGZT · Special | Nico Corporation | 09/07/2017SE |
| K161680 | MEDICON Spinal Spreading SystemsGZT · Traditional | Medicon EG | 03/24/2017SE |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional | Tedan Surgical Innovations, LLC | 03/20/2017SE |
| K161004 | Self-retaining RetractorGZT · Traditional | Fetzer Medical GmbH & Co. KG | 09/09/2016SE |
| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookGZT · Traditional | Nico Corporation | 06/12/2015SE |
| K120691 | Brain PortGZT · Traditional | Nico Corporation | 06/05/2012SE |
| K113273 | Spotlight Access SystemGZT · Traditional | Johnson & Johnson | 01/27/2012SE |
| K112913 | Spotlight Access SystemGZT · Special | Johnson & Johnson | 12/16/2011SE |
| K093054 | Scalp Dura Retractor, Model KS00474GZT · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/15/2010SE |
| K090272 | Spetzler Scalp Retractor Clamps (Various Styles and Sizes)GZT · Traditional | Cardinal Health, Inc. | 03/18/2009SE |
| K071771 | Instrumed RetractorsGZT · Abbreviated | Instrumed International, Inc. | 08/02/2007SE |
| K071338 | Flex Arm Retractor SystemGZT · Traditional | Koros USA, Inc. | 05/29/2007SE |
| K062814 | Pipeline II Access SystemGZT · Traditional | Depuy Spine, Inc. | 12/15/2006SE |
| K060973 | Vycor Surgical Access SystemsGZT · Traditional | Vycor Medical, LLC | 07/26/2006SE |
| K060097 | Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00GZT · Traditional | KLS-Martin L.P. | 02/27/2006SE |
| K050706 | Harmony Port System, Model 1907 SeriesGZT · Traditional | Spinal Concepts, Inc. | 04/15/2005SE |
| K992898 | The Bright Medical Dilation Retractor SystemGZT · Traditional | Bright Medical Instruments | 10/21/1999SE |
| K964402 | Versatrac (TM) Lumbar Retractor SystemGZT · Traditional | V. Mueller Neuro/Spine | 01/23/1997SE |
| K960807 | Tew Cranial/Spinal Retractor Model A1090GZT · Traditional | Ohio Medical Instrument Co., Inc. | 05/17/1996SE |
| K945040 | Hamid Hook Attachment Device for Hemilaminectomy RetractorGZT · Traditional | Hamid M. Mehdizadeh, M.D. | 01/13/1995SE |
| K935529 | Cervical Self-Retaining RetractorGZT · Traditional | T. Korossurgical Instruments Corp. | 03/22/1994SE |
| K924876 | TENS Device for Relief of Chronic Pain, ModifiedGZT · Traditional | Graham-Field, Inc. | 03/01/1994SE |
| K913233 | Codman Lhalo Split Ring Retractor SystemGZT · Traditional | Codman & Shurtleff, Inc. | 07/31/1991SE |
| K910621 | Blades for Spinal Laminectomy RetractorGZT · Traditional | International Hospital Supply Co. | 04/01/1991SE |
| K905445 | Adson-Beckman Retractor, SpinalGZT · Traditional | A. Henniss | 01/25/1991SE |
| K902517 | Neurosurgical Headframe AccessoriesGZT · Traditional | Sims Surgical, Inc. | 07/03/1990SE |
| K885120 | Esi Model MS-103GZT · Traditional | Electrical Systems Div. | 01/19/1990SE |
| K896156 | Compass(Tm) Stereotactic Retractor SystemGZT · Traditional | Stereotactic Medical Systems, Inc. | 12/06/1989SE |
| K895395 | V. Mueller Rhoton Self-Retaining Brain RetractorGZT · Traditional | Baxter Healthcare Corp | 10/19/1989SE |
| K895537 | Modified Memory Retractor ArmGZT · Traditional | Medical Equipment Development Co., Inc. | 09/22/1989SE |
| K892543 | Neurosurical Retractors - Various TypesGZT · Traditional | Zinnanti Surgical Instruments, Inc. | 05/05/1989SE |
| K882071 | Crank Frame RetractorGZT · Traditional | Karlin Technology, Inc. | 06/10/1988SE |
| K881160 | Crank Frame RetractorGZT · Traditional | T. Korossurgical Instruments Corp. | 04/06/1988SE |
| K874829 | Medco Memory Retractor SystemGZT · Traditional | Medical Equipment Development Co., Inc. | 03/24/1988SE |
| K874956 | Self-Retaining Retractor for NeurosurgeryGZT · Traditional | Solway, Inc. | 01/28/1988SE |
| K873691 | Cedar(Tm) Retractor RingGZT · Traditional | Cedar Surgical, Inc. | 09/28/1987SE |
| K830332 | Budde-Halo RetractorGZT · Traditional | Ohio Medical Instrument Co., Inc. | 03/02/1983SE |
| K801855 | Cyclopac TENSGZT · Traditional | Dow Corning Wright | 08/13/1980SE |
| K801151 | Disposable Skin RetractorGZT · Traditional | Cimarron Instruments, Inc. | 05/20/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2822-2018 Class II | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part…Mislabeled hook pouch included a transport/storage label rather than the product label containing key… | Nico Corp. | 06/19/2018Terminated |
| Z-0673-2013 Class I | Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product…Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber… | Vycor Medical, Inc. | 08/21/2012Terminated |
| Z-2201-2012 Class II | 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that…BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on… | Nico Corp. | 07/17/2012Terminated |
| Z-2200-2012 Class II | 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that…BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on… | Nico Corp. | 07/17/2012Terminated |
| Z-0880-2008 | Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component…Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple… | Abbott Spine | 12/19/2007Terminated |