FDA product code GXH: Device, Surgical, Cryogenic
GXH is the FDA product code for device, surgical, cryogenic. It is a Class II device, regulated under 21 CFR 882.4250 and reviewed by the Neurology panel. FDA has cleared 23 510(k) submissions under GXH, 5 in the last five years, from 8 different applicants. The average 510(k) review took 93 days (median 60); 44 days on average over the last three years. FDA has posted 2 recalls for GXH devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Surgical, Cryogenic |
| Device class | Class II |
| Regulation | 21 CFR 882.4250 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GXH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 262 |
| 2018 | 3 | 53 |
| 2020 | 1 | 281 |
| 2021 | 1 | 130 |
| 2022 | 1 | 74 |
| 2023 | 1 | 29 |
| 2024 | 2 | 29 |
| 2025 | 1 | 59 |
Compare with all 510(k) review times · Search every GXH clearance
Top GXH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Myoscience, Inc. | 8 | 2018-02-28 |
| AtriCure, Inc. | 7 | 2025-04-10 |
| Pacira Biosciences, Inc. | 2 | 2024-12-26 |
| Spembly Medical , Ltd. | 2 | 1983-08-12 |
| Pacira Pharmaceuticals, Inc. | 1 | 2021-09-10 |
3 more applicants have GXH clearances. See the full list in Caduvo.
Most recent GXH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250371 | AtriCure, Inc. | cryoICE cryoXT cryoablation probe (cryoXT) | 2025-04-10 | 59 |
| K243677 | Pacira Biosciences, Inc. | iovera° System | 2024-12-26 | 29 |
| K243157 | AtriCure, Inc. | AtriCure cryoICE BOX (ACM) | 2024-10-29 | 29 |
| K233170 | AtriCure, Inc. | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | 2023-10-26 | 29 |
| K220656 | Pacira Biosciences, Inc. | iovera System | 2022-05-20 | 74 |
Recalls for GXH devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-07-01.
Frequently asked questions
What is FDA product code GXH?
GXH is the FDA product code for device, surgical, cryogenic. It is a Class II device, regulated under 21 CFR 882.4250 and reviewed by the Neurology panel.
What device class is GXH?
Class II, regulation 21 CFR 882.4250. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXH?
Across 23 cleared submissions the average was 93 days from receipt to decision (median 60).
Which companies have the most GXH clearances?
Myoscience, Inc. (8); AtriCure, Inc. (7); Pacira Biosciences, Inc. (2); Spembly Medical , Ltd. (2); Pacira Pharmaceuticals, Inc. (1).
Have GXH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code GXH
- Run a recall and safety report across every GXH manufacturer
- Watch product code GXH 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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