{
  "format": "devicerts.device.v1",
  "cite_as": "EndoTool IV Cloud 1.0, Glooko, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/endotool-iv-cloud-1-0-ndc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/endotool-iv-cloud-1-0-ndc",
    "json_url": "https://devicerts.com/devices/endotool-iv-cloud-1-0-ndc.json",
    "markdown_url": "https://devicerts.com/devices/endotool-iv-cloud-1-0-ndc.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": "2026-11-14",
    "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/endotool-iv-cloud-1-0-ndc",
    "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": "EndoTool IV Cloud 1.0",
    "registry_name": "EndoTool IV Cloud 1.0",
    "url": "https://devicerts.com/devices/endotool-iv-cloud-1-0-ndc",
    "manufacturer": {
      "name": "Glooko, Inc.",
      "url": "https://devicerts.com/manufacturers/glooko-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K260910",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "NDC"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The EndoTool IV Cloud 1.0 is a Calculator, Drug Dose (FDA regulation 868.1890), designed to assist in the precise calculation and administration of intravenous drug dosages. This digital tool supports anesthesiology workflows by automating calculations to enhance patient safety and reduce human error during critical procedures.\n\nSupplied as a cloud-based software solution, the EndoTool IV Cloud 1.0 is intended for single-use per session and does not require physical sterilization. It operates within Class 2 regulatory standards and has received FDA 510(k) clearance under the Traditional pathway (K260910). No MRI safety or physical size specifications are noted in the regulatory submission.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "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": "K260910",
      "number_label": null,
      "device_udi_di": null,
      "date": "2026-05-01",
      "date_kind": "decision",
      "decision_code": "SESE",
      "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": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K260910",
              "registries": [
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            }
          ]
        },
        {
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    },
    {
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        {
          "label": "Device class",
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            {
              "value": "Class II",
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 868.1890",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Anesthesiology",
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            }
          ]
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          "values": [
            {
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            }
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        }
      ]
    }
  ]
}