Ecor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- ECOR EUDAMED
- Device Name
- gammaCore Sapphire EUDAMED
- Model / Reference
- gammaCore Sapphire Device Kit 93-days EUDAMED10016-20303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815203020218 EUDAMED
- Basic UDI-DI
- B-00815203020218 EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
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.
Frequently asked questions
What is the primary clinical application for the gammaCore Sapphire device, and how does it work?
The gammaCore Sapphire is a Non-Invasive Vagus Nerve Stimulator (NIVNS) designed specifically for headache management and related neurological conditions. It operates by delivering controlled electrical stimulation to the vagus nerve via a handheld device placed on the neck, helping modulate neurological activity without surgery or implants. This approach is classified under FDA’s 510(k) pathway and the EU’s Medical Device Directive (MDD) for non-invasive neuromodulation.
Is the gammaCore Sapphire device single-use or reusable, and what are the storage requirements?
The gammaCore Sapphire is supplied as a single-use, non-sterile kit (Reference: 10016-20303) with a 93-day shelf life from the manufacturing date. Since it is non-reusable, each kit must be discarded after one use. Storage conditions are not explicitly detailed in the data, but typical non-invasive neuromodulation devices require protection from extreme temperatures and moisture until use.
What regulatory pathways does the gammaCore Sapphire follow, and how does it classify under FDA and EU standards?
The gammaCore Sapphire is classified as a Class IIa medical device under FDA’s 510(k) pathway, with a substantially equivalent (SESE) decision, and authorized via FDA 510K clearance (K182369). In the EU, it complies with the Medical Device Directive (MDD) and is distributed by MDSS GmbH (DE-AR-000005430). Both pathways confirm its use for non-invasive vagus nerve stimulation in headache and neurological applications.
Does the gammaCore Sapphire device contain any animal-derived materials or latex, and what safety precautions should be considered?
The gammaCore Sapphire is non-latex and contains no animal tissues or medicinal products, reducing risks of allergic reactions or contamination. However, since it is non-sterile, clinical settings should follow standard infection control protocols (e.g., hand hygiene, surface disinfection) when handling the device. It is also non-implantable, eliminating risks associated with surgical implantation.
How can I identify the correct model and ensure I’m purchasing the right version of the gammaCore Sapphire?
The gammaCore Sapphire is supplied as the gammaCore Sapphire Device Kit (93-days) with the UDI identifier B-00815203020218. Verify the reference number (10016-20303) and shelf-life date (93 days from manufacture) to confirm the correct model. The device is active (not a measuring tool) and intended for single-use only, so check for the latest version (v1) and ensure compatibility with your clinical workflow.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: electroCore (ECOR) Stock Price & Overview, electroCore - Wikipedia, electroCore, Inc. (ECOR) Stock Price, News, Quote & History - Yahoo Finance, electroCore (ECOR) Company Profile & Description - Stock Analysis, electroCore, Inc. (ECOR) Stock Price & News - Google Finance
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191830 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K203546 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K211856 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K182369 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00815203020218 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ElectroCore, Inc.
- EUDAMED SRN
- US-MF-000036987
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 038cebaf-4adc-454a-954f-57c2385e51cc 85 fields · synced Sep 18, 2026
- FDA 510(k) K191830 1 fields · synced May 18, 2026