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510(k) K203546

gammaCore Sapphire by Electrocore, Inc. — Product Code PKR

K203546 is an FDA 510(k) premarket notification submitted by Electrocore, Inc. for the device "gammaCore Sapphire". The FDA issued a decision of Substantially Equivalent on February 12, 2021. The device falls under product code PKR (Non-Invasive Vagus Nerve Stimulator - Headache), a Class II device regulated under 21 CFR 882.5892. Electrocore, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2021
Date Received
December 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Invasive Vagus Nerve Stimulator - Headache
Device Class
Class II
Regulation Number
882.5892
Review Panel
NE
Submission Type

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.

Other clearances by Electrocore, Inc.

  • K211856 — gammaCore Sapphire (September 10, 2021)
  • K191830 — gammaCore Sapphire (March 26, 2020)
  • K182369 — gammaCore Sapphire (November 27, 2018)
  • K180538 — gammaCore Sapphire (March 30, 2018)
  • K173442 — gammaCore-S (January 23, 2018)
  • K171306 — gammaCore-S (May 30, 2017)
  • DEN150048 — gammaCore Non-invasive Vagus Nerve Stimulator (April 14, 2017)

Other clearances for product code PKR

  • K211856 — gammaCore Sapphire (September 10, 2021)
  • K191830 — gammaCore Sapphire (March 26, 2020)
  • K182369 — gammaCore Sapphire (November 27, 2018)
  • K180538 — gammaCore Sapphire (March 30, 2018)
  • K173442 — gammaCore-S (January 23, 2018)
  • K172270 — gammaCore-2 (December 7, 2017)
  • K171306 — gammaCore-S (May 30, 2017)
  • DEN150048 — gammaCore Non-invasive Vagus Nerve Stimulator (April 14, 2017)

FDA data resources