DeviceClearance

Product code PDQ— Ear, Nose, Throat

ATEC IOM Accessory Instruments

Classification name
Neurosurgical Nerve Locator
Device class
Class 2
Regulation
21 CFR 874.1820
Advisory panel
Ear, Nose, Throat
Total cleared
36
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 PDQ under 21 CFR 874.1820, via openFDA

Market context for product code PDQ

FDA has cleared 36 devices under product code PDQ between 2013 and 2026, filed by 21 applicant companies. 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.

Clearances per year

Top applicants under product code PDQ

Recent clearances under product code PDQ

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