Ecor

by ElectroCore, Inc. 20 variants

Ref 10016-20303Model gammaCore Sapphire Device Kit 93-days

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211856↗

+3 more

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00815203020218 Basic UDI-DI 00815203020218UDI-DI	Date24 Oct 2024Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK211856	Date10 Sep 2021Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK203546	Date12 Feb 2021Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK191830	Date26 Mar 2020Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK182369	Date27 Nov 2018Issued	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-00815203020218 — open Devices and search for it
FDA 510(k) database 510(k) number K211856
FDA 510(k) database 510(k) number K203546
FDA 510(k) database 510(k) number K191830
FDA 510(k) database 510(k) number K182369

Across registries

2 registries list this device

EUDAMED Basic UDI-DI B-00815203020218 registered 24 Oct 2024 Active
FDA 510(k) K211856 decided 10 Sep 2021 Active· +3 more in the status table

Timeline

5 dated events

27 Nov 2018 Cleared FDA 510(k) K182369
26 Mar 2020 Cleared FDA 510(k) K191830
12 Feb 2021 Cleared FDA 510(k) K203546
10 Sep 2021 Cleared FDA 510(k) K211856
24 Oct 2024 Registered EUDAMED B-00815203020218

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

United States FDA 510(k) Active
European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Model / reference: gammaCore Sapphire Device Kit 93-days, 10016-20303

Primary DI / UDI-DI: 00815203020218
Basic UDI-DI: B-00815203020218
EMDN code: Z12101106 Neurological stimulators

Device class: Class IIa
EU registration type: Legacy device (under a directive)
EU market of registration: France

Manufacturer details

EUDAMED SRN: US-MF-000036987
Authorised representative: MDSS GmbH DE-AR-000005430

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The gammaCore Sapphire is a Non-Invasive Vagus Nerve Stimulator (Nomenclature Code: Z12101106) designed for the non-invasive stimulation of the vagus nerve to address neurological conditions. It operates as a Class IIa medical device, intended for use in headache management and related neurological applications, as classified under FDA’s 510(k) pathway and the EU’s Medical Device Directive (MDD).

This device is supplied as a single-use, non-sterile kit (Reference: 10016-20303) with a 93-day shelf life, intended for use in clinical settings. It is non-implantable, non-reusable, and non-latex, with no associated risk of animal tissue or medicinal product interaction. The device carries UDI identifiers (B-00815203020218) and is authorized under FDA’s 510K clearance and EU’s MDD compliance, adhering to regulatory standards for non-invasive neuromodulation.

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Properties

Other properties (12, all answered No)