[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NKX":3},{"classification":4,"mappedDevices":41,"similarCandidates":42,"relatedClassifications":125,"syncDates":140},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":34,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":38,"pma_count":39,"event_count":40},4205,"NKX","Needle, Phacoemulsification, Reprocessed","2","886.4670","OP","Ophthalmic","1","Needle for phacoemulsification device to remove cataractous lens.  Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a \"reprocessed\" needle.  The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https:\u002F\u002Fwww.govinfo.gov\u002Fcontent\u002Fpkg\u002FFR-2005-09-29\u002Fpdf\u002F05-19510.pdf).",false,{"openfda":16,"definition":13,"device_name":7,"review_code":30,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":10,"gmp_exempt_flag":31,"third_party_flag":32,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":30,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":33},{"k_number":17,"fei_number":23,"registration_number":27},[18,19,20,21,22],"K050518","K012698","K012579","K030179","K060648",[24,25,26],"3002299608","1000114111","2025303",[28,26,29],"3032391","1054713","","N","Y","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",11,"2013-07-10",5,0,12,[],[43,52,61,70,79,87,95,103,110,118],{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},946,"水晶体乳化術白内障摘出ユニット","Ⅲ","17596000",0.344828,0.255892,0.722977,0.0327869,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},3608,"再使用可能な吸引用針","Ⅰ","37462000",0.25,0.204698,0.676209,0.0312805,{"medical_device_id":62,"generic_name":63,"class_classification":64,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":69},3202,"再製造胸部用トロカール","Ⅱ","70218002",0.226415,0.210243,0.661893,0.0297095,{"medical_device_id":71,"generic_name":72,"class_classification":73,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},25,"再使用可能な心臓吸引用針","Ⅳ","44136000",0.216667,0.172414,0.679555,0.0294691,{"medical_device_id":80,"generic_name":81,"class_classification":73,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":86},1161,"再製造心臓用カテーテル型電極","46359004",0.19403,0.204878,0.670374,0.0278638,{"medical_device_id":88,"generic_name":89,"class_classification":64,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},3204,"再製造腹部用トロカール","61814002",0.218182,0.20765,0.643421,0.0270516,{"medical_device_id":96,"generic_name":97,"class_classification":55,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},3597,"再使用可能なフィルタ付針","16266001",0.173077,0.159322,0.69017,0.0269841,{"medical_device_id":104,"generic_name":105,"class_classification":55,"jmdn_code":106,"name_similarity":99,"definition_similarity":107,"vector_similarity":108,"score":109},4206,"再使用可能な気道確保用針","12732001",0.16129,0.658463,0.0249346,{"medical_device_id":111,"generic_name":112,"class_classification":55,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":117},3598,"再使用可能な皮下注射ポート用針","17180001",0.175676,0.153595,0.644874,0.0241841,{"medical_device_id":119,"generic_name":120,"class_classification":55,"jmdn_code":121,"name_similarity":99,"definition_similarity":122,"vector_similarity":123,"score":124},3607,"再使用可能な生検用針","31730000",0.196532,0.638267,0.0232841,[126,130,134,137],{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"HQC","Unit, Phacofragmentation",316,{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"MUS","Fluidic, Phacoemulsification\u002FPhacofragmentation",1,{"product_code":135,"device_name":136,"device_class":8,"k510_count":39},"MXO","Laser, System, Phacolysis",{"product_code":138,"device_name":139,"device_class":8,"k510_count":39},"QDW","Phaco Kit",{"510k":141,"classification":142,"enforcement":143,"event":144,"pma":145,"warning_letter":146},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]