FDA Product Code PKR: Non-invasive Vagus Nerve Stimulator - Headache
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.
Leading manufacturers include Electrocore, Inc. and Electrocore, LLC.
9
Total
8
Cleared
146d
Avg days
2017
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Non-invasive Vagus Nerve Stimulator - Headache Devices (Product Code PKR)
9 devices
Cleared
Sep 10, 2021
gammaCore Sapphire
Electrocore, Inc.
Neurology
86d
Cleared
Feb 12, 2021
gammaCore Sapphire
Electrocore, Inc.
Neurology
70d
Cleared
Mar 26, 2020
gammaCore Sapphire
Electrocore, Inc.
Neurology
261d
Cleared
Nov 27, 2018
gammaCore Sapphire
Electrocore, Inc.
Neurology
88d
Cleared
Mar 30, 2018
gammaCore Sapphire
Electrocore, LLC
Neurology
30d
Cleared
Jan 23, 2018
gammaCore-S
Electrocore, LLC
Neurology
78d
About Product Code PKR - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PKR since 2017, with 8 receiving FDA clearance (average review time: 146 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.