FDA product code GZT: Retractor, Self-Retaining, For Neurosurgery
GZT is the FDA product code for retractor, self-retaining, for neurosurgery. It is a Class II device, regulated under 21 CFR 882.4800 and reviewed by the Neurology panel. FDA has cleared 44 510(k) submissions under GZT, 2 in the last five years, from 38 different applicants. The average 510(k) review took 112 days (median 56); 364 days on average over the last three years. FDA has posted 6 recalls for GZT devices.
Classification
| Field | Value |
|---|---|
| Device name | Retractor, Self-Retaining, For Neurosurgery |
| Device class | Class II |
| Regulation | 21 CFR 882.4800 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GZT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 207 |
| 2018 | 1 | 174 |
| 2020 | 1 | 30 |
| 2021 | 1 | 120 |
| 2022 | 1 | 438 |
| 2026 | 1 | 364 |
Compare with all 510(k) review times · Search every GZT clearance
Top GZT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nico Corporation | 3 | 2017-09-07 |
| Johnson & Johnson | 2 | 2012-01-27 |
| Ohio Medical Instrument Co., Inc. | 2 | 1996-05-17 |
| T. Korossurgical Instruments Corp. | 2 | 1994-03-22 |
| Medical Equipment Development Co., Inc. | 2 | 1989-09-22 |
33 more applicants have GZT clearances. See the full list in Caduvo.
Most recent GZT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252995 | SurGenTec, LLC | Durashield Device Kit | 2026-09-17 | 364 |
| K210615 | Thompson Surgical Instruments, Inc. | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | 2022-05-13 | 438 |
| K202694 | Vycor Medical, Inc. | Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family) | 2021-01-14 | 120 |
| K202072 | Minnetronix Neuro, Inc. | MindsEye Expandable Port | 2020-08-26 | 30 |
| K180610 | Geister Medizin Technik GmbH | Geister retractor for neuro - and spine surgery | 2018-08-29 | 174 |
Recalls for GZT devices
6 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-19.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code GZT?
GZT is the FDA product code for retractor, self-retaining, for neurosurgery. It is a Class II device, regulated under 21 CFR 882.4800 and reviewed by the Neurology panel.
What device class is GZT?
Class II, regulation 21 CFR 882.4800. Typical premarket route: 510(k).
How long does a 510(k) take for product code GZT?
Across 44 cleared submissions the average was 112 days from receipt to decision (median 56).
Which companies have the most GZT clearances?
Nico Corporation (3); Johnson & Johnson (2); Ohio Medical Instrument Co., Inc. (2); T. Korossurgical Instruments Corp. (2); Medical Equipment Development Co., Inc. (2).
Have GZT devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2018-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code GZT
- Run a recall and safety report across every GZT manufacturer
- Watch product code GZT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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