510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203546Substantially Equivalent

gammaCore Sapphire

Electrocore, Inc., Basking Ridge NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203546 is the FDA 510(k) clearance record for gammaCore Sapphire, a class II device, cleared for Electrocore, Inc. on under FDA product code PKR (Non-Invasive Vagus Nerve Stimulator - Headache). FDA's definition for product code PKR reads: "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". FDA records list 8 510(k) clearances for Electrocore, Inc., from to . As of , FDA records show no recalls naming K203546.

Clearance record

Decision date
Received
(70 days to decision)
Product code
PKR Non-Invasive Vagus Nerve Stimulator - Headache
Regulation
21 CFR 882.5892
Device class
Class II
Review panel
Neurology
Applicant
Electrocore, Inc. 150 Allen Rd., Suite 201, Basking Ridge NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PKR

Trailing 12 months

FDA records hold no clearances under product code PKR in the trailing twelve months.

FDA records show no clearances under product code PKR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PKR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260