{ "format": "devicerts.device.v1", "cite_as": "Smoklean Surgical Exhaust Apparatus, Sejong Medical Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/smoklean-fyd (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/smoklean-fyd", "json_url": "https://devicerts.com/devices/smoklean-fyd.json", "markdown_url": "https://devicerts.com/devices/smoklean-fyd.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA 510(k)", "url": "https://open.fda.gov/apis/device/510k/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" } ], "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/smoklean-fyd", "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": "Smoklean Surgical Exhaust Apparatus", "registry_name": "Smoklean", "url": "https://devicerts.com/devices/smoklean-fyd", "manufacturer": { "name": "Sejong Medical Co., Ltd", "url": "https://devicerts.com/manufacturers/sejong-medical-co-ltd", "country": "South Korea", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class I", "system": "EU MDD" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "08806182200229", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-08806182200229", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K173108", "registries": [ "FDA 510(k)" ] } ] } ], "product_codes": [ "FYD" ], "emdn": [ { "code": "Z12029099", "term": "VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER" } ], "gmdn": [], "description": { "text": "The Smoklean Surgical Exhaust Apparatus is a Class II surgical device designed for the removal of smoke, fumes, and airborne contaminants generated during surgical procedures. It functions as an exhaust system to improve operating room air quality by capturing and filtering particulate matter, reducing exposure to healthcare personnel and patients.\n\nThis device is supplied as a reusable system and is intended for use in surgical settings, including general and plastic surgery. It complies with FDA 510(k) clearance under regulation number 878.5070 and the Medical Device Directive (MDD). The apparatus is not MRI-safe and requires proper installation and maintenance as per manufacturer guidelines to ensure effective operation and longevity.", "ai_generated": true, "generated_on": "2026-09-18", "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": "EUDAMED", "region": "European Union", "type": "CE/MDD", "number": "B-08806182200229", "number_label": "Basic UDI-DI", "device_udi_di": "08806182200229", "date": "2026-05-28", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K173108", "number_label": null, "device_udi_di": null, "date": "2018-05-18", "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": "Identity", "fields": [ { "label": "Model / reference", "values": [ { "value": "SJ-SF-03", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "08806182200229", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-08806182200229", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K173108", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "FYD", "registries": [ "FDA 510(k)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Z12029099", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class I", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA 510(k)" ] } ] }, { "label": "Regulation", "values": [ { "value": "21 CFR Part 878.5070", "registries": [ "FDA 510(k)" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Spain", "registries": [ "EUDAMED" ] } ] }, { "label": "Advisory committee", "values": [ { "value": "General, Plastic Surgery", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA decision", "values": [ { "value": "SESE", "registries": [ "FDA 510(k)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Supplied sterile", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Reusable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Reprocessed single-use device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a substance derived from human blood or plasma", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains human tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Administering medicine", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Measuring function", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a medicinal substance", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] } ] } ] }