GZTClass II
Retractor, Self-Retaining, For Neurosurgery
21 CFR 882.4800 / Neurology
GZT is the FDA product code for Retractor, Self-Retaining, For Neurosurgery, a class II device type, regulated under 21 CFR 882.4800. As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- GZT
- Device name
- Retractor, Self-Retaining, For Neurosurgery
- Regulation
- 21 CFR 882.4800
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 44
- Ingested recalls
- 6
Clearances, product code GZT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1983 | 1 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 4 |
| 1990 | 2 |
| 1991 | 3 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code GZT| Applicant | Clearances |
|---|---|
| Nico Corporation | 3 |
| Johnson & Johnson | 2 |
| Medical Equipment Development Co., Inc. | 2 |
| Ohio Medical Instrument Co., Inc. | 2 |
| T. Korossurgical Instruments Corp. | 2 |
| Vycor Medical, Inc. | 2 |
| A. Henniss | 1 |
| Baxter Healthcare Corporation | 1 |
| Bright Medical Instruments | 1 |
| Medtronic, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.