{
  "format": "devicerts.device.v1",
  "cite_as": "Fms 287305, DePuy Mitek, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/fms-287305 (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/fms-287305",
    "json_url": "https://devicerts.com/devices/fms-287305.json",
    "markdown_url": "https://devicerts.com/devices/fms-287305.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-23",
    "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/fms-287305",
    "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": "Fms 287305",
    "registry_name": "FMS 287305",
    "url": "https://devicerts.com/devices/fms-287305",
    "manufacturer": {
      "name": "DePuy Mitek, Inc.",
      "url": "https://devicerts.com/manufacturers/fda-fei-1221934",
      "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": "Catalogue number",
        "values": [
          {
            "value": "287305",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "10886705000333",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K954465",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "HRX"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "41499",
        "term": "Arthroscopic shaver system blade, single-use"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "10886705000333",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2017-03-17",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K954465",
      "number_label": null,
      "device_udi_di": null,
      "date": "1995-11-09",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0658-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2015-11-20",
      "reason": "Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.",
      "applies": "this device",
      "via": "K954465"
    },
    {
      "number": "Z-0192-2014",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2013-08-29",
      "reason": "Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not  perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination",
      "applies": "this device",
      "via": "K954465"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "FMS",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Arthroscopic shaver system blade, single-use",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
          "values": [
            {
              "value": "287305",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
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        {
          "label": "Primary DI / UDI-DI",
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        {
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              "value": "HRX",
              "registries": [
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          ]
        },
        {
          "label": "GMDN term",
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            {
              "value": "Arthroscopic shaver system blade, single-use",
              "code": "41499",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Regulation number",
          "values": [
            {
              "value": "888.1100",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
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    {
      "group": "Properties",
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        {
          "label": "Supplied sterile",
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            {
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              "registries": [
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        {
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        {
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        {
          "label": "Lot / batch number",
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          "label": "Expiration date",
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          "label": "HCT/P",
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          "label": "Premarket exempt",
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        {
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}