Cervical Self-Retaining Retractor
FDA 510(k) K935529 · T. Korossurgical Instruments Corp.
510(k) numberK935529
Submission
- Device name
- Cervical Self-Retaining Retractor
- Applicant
- T. Korossurgical Instruments Corp.
Moorepark, CA, US - Received
- November 16, 1993
- Decision date
- March 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code GZT
| 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 |
More from Nico Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K001915 | Graft Marker RingMAB · Traditional | 04/27/2001SE |
| K002755 | Non-Absorbing Sternatomy Monofilament SutureLRN · Traditional | 12/04/2000SE |
| K954016 | Videoscope W/Irrigation SheathHRX · Traditional | 01/25/1996SN |
| K953998 | Discetome Tissue AspiratorHRX · Traditional | 12/04/1995SE |
| K954052 | Arthroscopic Grasper, Cup Forceps and CurettesHRX · Traditional | 11/06/1995SN |
| K954014 | Percutaneous Discectomy Cannula SystemHRX · Traditional | 11/06/1995SN |
| K931262 | Reusable/Interchangeable Shaft, Endoscopic ScissorGCJ · Traditional | 08/06/1993SE |
| K926585 | Thorocoscopy Self-Retaining RetractorGAD · Traditional | 08/06/1993SE |
| K926583 | Reusable Endoscopic Scissors, Grasper-MonopolarGCJ · Traditional | 08/06/1993SE |
| K931259 | Endoscopic or Thorascopic ForcepsGCJ · Traditional | 06/08/1993SE |
Questions and answers
When was Cervical Self-Retaining Retractor cleared by the FDA?
Cervical Self-Retaining Retractor (K935529) received a 510(k) decision of Substantially Equivalent on March 22, 1994, 126 days after the submission was received.
What is the product code of K935529?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.