{
  "format": "devicerts.device.v1",
  "cite_as": "Swift System, Emblation, Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/swift-system-ney (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/swift-system-ney",
    "json_url": "https://devicerts.com/devices/swift-system-ney.json",
    "markdown_url": "https://devicerts.com/devices/swift-system-ney.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-14",
    "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/swift-system-ney",
    "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": "Swift System",
    "registry_name": "Swift System",
    "url": "https://devicerts.com/devices/swift-system-ney",
    "manufacturer": {
      "name": "Emblation, Ltd.",
      "url": "https://devicerts.com/manufacturers/emblation-ltd",
      "country": "United Kingdom",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K181941",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "NEY"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Swift System is a Microwave Ablation System and Accessories designed for targeted tissue treatment. It delivers controlled microwave energy to precisely ablate skin lesions, including verrucas and warts, without disrupting the surrounding skin surface. The device operates within the regulatory classification of Class II medical devices, adhering to standards for microwave ablation technology.\n\nThe system is intended for use in clinical settings by trained healthcare professionals. It is supplied as a reusable device with disposable accessories, ensuring sterility and single-use compliance for patient safety. The Swift System is authorised under FDA 510K and MDR, with a regulatory designation of Substantially Equivalent to predicate devices. Storage and handling follow manufacturer guidelines to maintain performance and sterility.",
      "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": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K181941",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-10-18",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
      "date_kind": null,
      "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": [
    {
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      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K181941",
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            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "NEY",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 878.4400",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "General, Plastic Surgery",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
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            {
              "value": "SESE",
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            }
          ]
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  ]
}