{
  "format": "devicerts.device.v1",
  "cite_as": "TruDi NAV Suction Instruments, Acclarent, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/trudi-nav-suction-instruments-pgw (data as of 2026-11-15).",
  "source": {
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    "json_url": "https://devicerts.com/devices/trudi-nav-suction-instruments-pgw.json",
    "markdown_url": "https://devicerts.com/devices/trudi-nav-suction-instruments-pgw.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
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    "registry_records_last_synced": "2026-10-11",
    "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/trudi-nav-suction-instruments-pgw",
    "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": "TruDi NAV Suction Instruments",
    "registry_name": "TruDi NAV Suction Instruments",
    "url": "https://devicerts.com/devices/trudi-nav-suction-instruments-pgw",
    "manufacturer": {
      "name": "Acclarent, Inc.",
      "url": "https://devicerts.com/manufacturers/acclarent-inc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
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      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
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        "system": "US FDA"
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        "values": [
          {
            "value": "K180948",
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    ],
    "product_codes": [
      "PGW"
    ],
    "emdn": [],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
  "authorizations": [
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      "number_label": null,
      "device_udi_di": null,
      "date": "2018-07-20",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "withdrawn": null,
      "status": "Active",
      "status_note": null,
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    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-2507-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-07-09",
      "reason": "Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi  Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.",
      "applies": "this device",
      "via": "K180948"
    },
    {
      "number": "Z-0415-2022",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-11-12",
      "reason": "Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.",
      "applies": "this device",
      "via": "K180948"
    },
    {
      "number": "Z-0824-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-03-06",
      "reason": "The firm became aware that three (3) lots of the NAV Suction Instruments  contain calibration issues causing incorrect tip orientation display in the system.",
      "applies": "this device",
      "via": "K180948"
    },
    {
      "number": "Z-0825-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-03-06",
      "reason": "The firm became aware that three (3) lots of the NAV Suction Instruments  contain calibration issues causing incorrect tip orientation display in the system.",
      "applies": "this device",
      "via": "K180948"
    },
    {
      "number": "Z-0826-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-03-06",
      "reason": "The firm became aware that three (3) lots of the NAV Suction Instruments  contain calibration issues causing incorrect tip orientation display in the system.",
      "applies": "this device",
      "via": "K180948"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
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    {
      "group": "Classification",
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        {
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}