FDA product code GXW: Echoencephalograph
GXW is the FDA product code for echoencephalograph. It is a Class II device, regulated under 21 CFR 882.1240 and reviewed by the Neurology panel. FDA has cleared 7 510(k) submissions under GXW, from 6 different applicants. The average 510(k) review took 126 days (median 164).
Classification
| Field | Value |
|---|---|
| Device name | Echoencephalograph |
| Device class | Class II |
| Regulation | 21 CFR 882.1240 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GXW clearance
Top GXW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Storz Instrument Co. | 2 | 1977-05-06 |
| Hewlett-Packard Co. | 1 | 1992-09-28 |
| Toshiba America Medical Systems, In.C | 1 | 1990-10-05 |
| Diasonics, Inc. | 1 | 1986-02-07 |
| Advanced Technology Laboratories, Inc. | 1 | 1984-05-25 |
1 more applicants have GXW clearances. See the full list in Caduvo.
Most recent GXW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921863 | Hewlett-Packard Co. | SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS | 1992-09-28 | 164 |
| K903085 | Toshiba America Medical Systems, In.C | SMS-712NA | 1990-10-05 | 85 |
| K853432 | Diasonics, Inc. | 5.0 IOP & 7.5 IOP PROBES | 1986-02-07 | 176 |
| K833522 | Advanced Technology Laboratories, Inc. | NEURO SECTOR FIXATION DEVICE | 1984-05-25 | 249 |
| K821736 | Rabar, Inc. | ECHO-PULSE KM555 | 1982-12-09 | 178 |
Recalls for GXW devices
openFDA lists no recalls for product code GXW.
Frequently asked questions
What is FDA product code GXW?
GXW is the FDA product code for echoencephalograph. It is a Class II device, regulated under 21 CFR 882.1240 and reviewed by the Neurology panel.
What device class is GXW?
Class II, regulation 21 CFR 882.1240. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXW?
Across 7 cleared submissions the average was 126 days from receipt to decision (median 164).
Which companies have the most GXW clearances?
Storz Instrument Co. (2); Hewlett-Packard Co. (1); Toshiba America Medical Systems, In.C (1); Diasonics, Inc. (1); Advanced Technology Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GXW
- Run a recall and safety report across every GXW manufacturer
- Watch product code GXW 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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