DeviceClearance

Product code QWP— Ear, Nose, Throat

Waypoint GPS

Classification name
Optical Neurosurgical Nerve Locator
Device class
Class 2
Regulation
21 CFR 874.1820
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

FDA classification definition

“To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.”

— U.S. Food and Drug Administration, device classification record for product code QWP under 21 CFR 874.1820, via openFDA

Market context for product code QWP

FDA has cleared 1 device under product code QWP, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QWP

Recent clearances under product code QWP

Data sourced from openFDA. This site is unofficial and independent of the FDA.