FDA product code GXQ: Dura Substitute
GXQ is the FDA product code for dura substitute. It is a Class II device, regulated under 21 CFR 882.5910 and reviewed by the Neurology panel. FDA has cleared 43 510(k) submissions under GXQ, 4 in the last five years, from 22 different applicants. The average 510(k) review took 146 days (median 99); 152 days on average over the last three years. FDA has posted 23 recalls for GXQ devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dura Substitute |
| Device class | Class II |
| Regulation | 21 CFR 882.5910 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GXQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 58 |
| 2019 | 1 | 177 |
| 2022 | 1 | 135 |
| 2023 | 1 | 269 |
| 2025 | 2 | 152 |
Compare with all 510(k) review times · Search every GXQ clearance
Top GXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Collagen Matrix, Inc. | 5 | 2025-11-18 |
| Medtronic Neurosurgery | 4 | 2016-11-02 |
| Integra Lifesciences Corp. | 4 | 2007-08-23 |
| Acera Surgical, Inc. | 3 | 2017-11-27 |
| Aesculap, Inc. | 3 | 2013-06-04 |
17 more applicants have GXQ clearances. See the full list in Caduvo.
Most recent GXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251191 | Collagen Matrix, Inc. | Collagen Dura Regeneration Membrane - Repair | 2025-11-18 | 215 |
| K250420 | Helios Biomedical, Inc. | Helios Dura Regeneration Matrix | 2025-05-14 | 90 |
| K223445 | Nurami Medical , Ltd. | ArtiFascia | 2023-08-10 | 269 |
| K212943 | Synthes (USA) Products, LLC | SyntheCel Dura Repair | 2022-01-28 | 135 |
| K183513 | LeMaitre Vascular, Inc. | XenoSure Dura Biologic Patch | 2019-06-13 | 177 |
Recalls for GXQ devices
23 product recalls in 10 recall events; 5 initiated in the last five years and 3 still open. Most recent: 2024-11-22.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code GXQ?
GXQ is the FDA product code for dura substitute. It is a Class II device, regulated under 21 CFR 882.5910 and reviewed by the Neurology panel.
What device class is GXQ?
Class II, regulation 21 CFR 882.5910. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXQ?
Across 43 cleared submissions the average was 146 days from receipt to decision (median 99).
Which companies have the most GXQ clearances?
Collagen Matrix, Inc. (5); Medtronic Neurosurgery (4); Integra Lifesciences Corp. (4); Acera Surgical, Inc. (3); Aesculap, Inc. (3).
Have GXQ devices been recalled?
Yes: 23 product recalls across 10 recall events; the most recent began 2024-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code GXQ
- Run a recall and safety report across every GXQ manufacturer
- Watch product code GXQ 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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