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gammaCore Sapphire Device Starter Kit

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K180538

by ElectroCore, Inc.

Identity

Trade Name
gammaCore Sapphire Device Starter Kit FDA UDI
Generic Name
Migraine-therapy peripheral nerve electrical stimulator FDA UDI
Device Name
gammaCore Sapphire 6-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. FDA UDI
Model / Reference
13016-04002 FDA UDI
Description
gammaCore Sapphire 6-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. FDA UDI

Identifiers

Catalog Number
13016-04002 FDA UDI
Primary DI / UDI-DI
00815203021277 FDA UDI
FDA Product Code
PKR FDA UDI
QAK FDA UDI
GMDN Term
Migraine-therapy peripheral nerve electrical stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5892 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Migraine-therapy peripheral nerve electrical stimulator

gammaCore Sapphire Device Starter Kit by ElectroCore, Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Migraine-therapy peripheral nerve electrical stimulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
ElectroCore, Inc.
FDA Applicant
Electrocore, LLC

Sources (2)

  • FDA UDI d76d1d40-8afb-481c-8b5e-cb6a8f712622 60 fields · synced Jun 18, 2026
  • FDA 510(k) K180538 1 fields · synced May 25, 2026