FDA product code QWP: Optical Neurosurgical Nerve Locator
QWP is the FDA product code for optical neurosurgical nerve locator. It is a Class II device, regulated under 21 CFR 874.1820 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under QWP, 1 in the last five years. The average 510(k) review took 298 days (median 298).
Definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Classification
| Field | Value |
|---|---|
| Device name | Optical Neurosurgical Nerve Locator |
| Device class | Class II |
| Regulation | 21 CFR 874.1820 |
| Review panel | NE — Neurology |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for QWP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 298 |
Compare with all 510(k) review times · Search every QWP clearance
Top QWP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Waypoint Orthopedics, Inc. | 1 | 2023-05-12 |
Most recent QWP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222106 | Waypoint Orthopedics, Inc. | Waypoint GPS | 2023-05-12 | 298 |
Recalls for QWP devices
openFDA lists no recalls for product code QWP.
Frequently asked questions
What is FDA product code QWP?
QWP is the FDA product code for optical neurosurgical nerve locator. It is a Class II device, regulated under 21 CFR 874.1820 and reviewed by the Neurology panel.
What device class is QWP?
Class II, regulation 21 CFR 874.1820. Typical premarket route: 510(k).
How long does a 510(k) take for product code QWP?
Across 1 cleared submissions the average was 298 days from receipt to decision (median 298).
Which companies have the most QWP clearances?
Waypoint Orthopedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QWP
- Run a recall and safety report across every QWP manufacturer
- Watch product code QWP 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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