DeviceClearance

Product code PKR— Neurology

gammaCore Sapphire

Classification name
Non-Invasive Vagus Nerve Stimulator - Headache
Device class
Class 2
Regulation
21 CFR 882.5892
Advisory panel
Neurology
Total cleared
9
First cleared
Most recent

FDA classification definition

“The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.”

— U.S. Food and Drug Administration, device classification record for product code PKR under 21 CFR 882.5892, via openFDA

Market context for product code PKR

FDA has cleared 9 devices under product code PKR between 2017 and 2021, filed by 3 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 PKR

Recent clearances under product code PKR

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