{
  "format": "devicerts.device.v1",
  "cite_as": "mJOULE System and Accessories, Sciton, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/mjoule-system-and-accessories-gex (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/mjoule-system-and-accessories-gex",
    "json_url": "https://devicerts.com/devices/mjoule-system-and-accessories-gex.json",
    "markdown_url": "https://devicerts.com/devices/mjoule-system-and-accessories-gex.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "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/mjoule-system-and-accessories-gex",
    "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": "mJOULE System and Accessories",
    "registry_name": "mJOULE System and Accessories",
    "url": "https://devicerts.com/devices/mjoule-system-and-accessories-gex",
    "manufacturer": {
      "name": "Sciton, Inc",
      "url": "https://devicerts.com/manufacturers/fda-fei-3001415984",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K213350",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GEX"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The mJOULE System and Accessories is a device used in general and plastic surgery procedures. It is substantially equivalent to a legally marketed device as determined by FDA 510(k) clearance.\n\nThe system is supplied by Sciton, Inc and was cleared via the traditional 510(k) pathway under product code GEX. It received FDA clearance on April 15, 2022, under K213350.",
      "ai_generated": true,
      "generated_on": "2026-09-23",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
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  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K213350",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-04-15",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "withdrawn": null,
      "status": "Active",
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    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
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  "eu_market_availability": null,
  "properties": [
    {
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        {
          "label": "510(k) Number",
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            {
              "value": "K213350",
              "registries": [
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            }
          ]
        },
        {
          "label": "FDA product code",
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            {
              "value": "GEX",
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        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 878.4810",
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          ]
        },
        {
          "label": "Advisory committee",
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              "value": "General, Plastic Surgery",
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}