{
  "format": "devicerts.device.v1",
  "cite_as": "AbbVie PEG, Abbvie Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/abbvie-peg-knt (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/abbvie-peg-knt",
    "json_url": "https://devicerts.com/devices/abbvie-peg-knt.json",
    "markdown_url": "https://devicerts.com/devices/abbvie-peg-knt.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/abbvie-peg-knt",
    "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": "AbbVie PEG",
    "registry_name": "ABBVIE PEG",
    "url": "https://devicerts.com/devices/abbvie-peg-knt",
    "manufacturer": {
      "name": "Abbvie Inc.",
      "url": "https://devicerts.com/manufacturers/abbvie-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": "K133087",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "KNT"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The AbbVie PEG is a polyethylene glycol (PEG) electrolyte solution designed for bowel preparation prior to colonoscopy or other lower gastrointestinal procedures. It functions as an osmotic laxative to clear the colon by drawing water into the intestines, facilitating effective cleansing of the gastrointestinal tract.\n\nThis device is supplied as a powder for oral suspension and is intended for single-use. It is classified under product code KNT and has received FDA 510K clearance through a traditional review process. The solution must be reconstituted with water as directed and is intended for use in clinical settings such as hospitals, endoscopy centers, or outpatient care facilities.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "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": "K133087",
      "number_label": null,
      "device_udi_di": null,
      "date": "2014-06-19",
      "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": "K133087",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "KNT",
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            }
          ]
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    {
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        {
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            {
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 876.5980",
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            }
          ]
        },
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          "label": "Advisory committee",
          "values": [
            {
              "value": "Gastroenterology, Urology",
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            }
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        }
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    }
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}