{ "format": "devicerts.device.v1", "cite_as": "Ecor, ElectroCore, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/ecor-10016-20303 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/ecor-10016-20303", "json_url": "https://devicerts.com/devices/ecor-10016-20303.json", "markdown_url": "https://devicerts.com/devices/ecor-10016-20303.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" }, { "registry": "FDA 510(k)", "url": "https://open.fda.gov/apis/device/510k/" } ], "registry_records_last_synced": "2026-10-25", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.", "attribution": "DevicErts, https://devicerts.com/devices/ecor-10016-20303", "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails." }, "device": { "name": "Ecor", "registry_name": "ECOR", "url": "https://devicerts.com/devices/ecor-10016-20303", "manufacturer": { "name": "ElectroCore, Inc.", "url": "https://devicerts.com/manufacturers/electrocore-inc", "country": "United States", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class IIa", "system": "EU MDD" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00815203020218", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00815203020218", "registries": [ "EUDAMED" ] } ] } ], "product_codes": [], "emdn": [ { "code": "Z12101106", "term": "NEUROLOGICAL STIMULATORS" } ], "gmdn": [], "description": { "text": "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).\n\nThis 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.", "ai_generated": true, "generated_on": "2026-09-18", "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record." }, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDD", "number": "B-00815203020218", "number_label": "Basic UDI-DI", "device_udi_di": "00815203020218", "date": "2024-10-24", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K211856", "number_label": null, "device_udi_di": null, "date": "2021-09-10", "date_kind": "issued", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K203546", "number_label": null, "device_udi_di": null, "date": "2021-02-12", "date_kind": "issued", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K191830", "number_label": null, "device_udi_di": null, "date": "2020-03-26", "date_kind": "issued", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K182369", "number_label": null, "device_udi_di": null, "date": "2018-11-27", "date_kind": "issued", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false } ], "no_longer_listed_by": [], "certificates": [], "recalls": [], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Model / reference", "values": [ { "value": "gammaCore Sapphire Device Kit 93-days", "registries": [ "EUDAMED" ] }, { "value": "10016-20303", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00815203020218", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00815203020218", "registries": [ "EUDAMED" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Z12101106", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class IIa", "registries": [ "EUDAMED" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "France", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Reusable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Reprocessed single-use device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a substance derived from human blood or plasma", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains human tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Administering medicine", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Measuring function", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a medicinal substance", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] } ] } ] }