FDA product code GXR: Cover, Burr Hole
GXR is the FDA product code for cover, burr hole. It is a Class II device, regulated under 21 CFR 882.5250 and reviewed by the Neurology panel. FDA has cleared 29 510(k) submissions under GXR, 3 in the last five years, from 19 different applicants. The average 510(k) review took 162 days (median 130); 97 days on average over the last three years. FDA has posted 1 recall for GXR devices.
Classification
| Field | Value |
|---|---|
| Device name | Cover, Burr Hole |
| Device class | Class II |
| Regulation | 21 CFR 882.5250 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GXR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 90 |
| 2020 | 2 | 250 |
| 2023 | 1 | 537 |
| 2024 | 1 | 29 |
| 2026 | 1 | 165 |
Compare with all 510(k) review times · Search every GXR clearance
Top GXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neos Surgery S.L | 4 | 2024-02-16 |
| Synthes (Usa) | 4 | 2004-11-17 |
| Ossdsign AB | 2 | 2018-10-12 |
| St Jude Medical | 2 | 2018-07-20 |
| NeuroPace, Inc. | 2 | 2014-07-11 |
14 more applicants have GXR clearances. See the full list in Caduvo.
Most recent GXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253447 | Orthocon, Inc. | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | 2026-03-16 | 165 |
| K240137 | Neos Surgery S.L | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | 2024-02-16 | 29 |
| K221606 | Chendu Medart Medical Scientific Co., Ltd. | Absorbable Cranial Flap Fixation System | 2023-11-21 | 537 |
| K192310 | Ossaware Biotech Co., Ltd. | Flap Fixator, Burr Hole Cover | 2020-06-03 | 282 |
| K192162 | Neurovention, LLC | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | 2020-03-13 | 217 |
Recalls for GXR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-06-02.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code GXR?
GXR is the FDA product code for cover, burr hole. It is a Class II device, regulated under 21 CFR 882.5250 and reviewed by the Neurology panel.
What device class is GXR?
Class II, regulation 21 CFR 882.5250. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXR?
Across 29 cleared submissions the average was 162 days from receipt to decision (median 130).
Which companies have the most GXR clearances?
Neos Surgery S.L (4); Synthes (Usa) (4); Ossdsign AB (2); St Jude Medical (2); NeuroPace, Inc. (2).
Have GXR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-06-02.
Next steps
- Run an FDA pathway report with predicate devices for product code GXR
- Run a recall and safety report across every GXR manufacturer
- Watch product code GXR 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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