[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OKS":3},{"classification":4,"mappedDevices":90,"similarCandidates":91,"relatedClassifications":174,"syncDates":175,"translation":182,"marketSummary":189,"recalls":210,"k510s":212,"pmas":292},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":84,"updated_at":85,"recall_count":86,"latest_recall_date":87,"k510_count":88,"pma_count":86,"event_count":89},1367,"OKS","Lacrimal Stents And Intubation Sets","U","","Unknown","OP","1","Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system.  Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":81,"product_code":6,"review_panel":11,"gmp_exempt_flag":82,"third_party_flag":82,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":12,"life_sustain_support_flag":82,"medical_specialty_description":10,"summary_malfunction_reporting":83},{"k_number":18,"fei_number":50,"registration_number":71},[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"K201606","K962151","K991238","K973633","K911109","K161373","K113536","K023758","K955671","K120886","K160710","K170247","K973872","K201892","K113508","K140290","K113118","K883233","K012108","K061404","K123831","K041869","K113867","K113316","K121142","K940508","K130375","K990672","K935233","K030353","K142914",[51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70],"3001236277","3015177648","1929756","1928237","3002807041","3009761573","3000314405","2242450","3002991496","1018470","1450662","1000286794","3002807310","3002808904","3004467263","1000306431","3003015552","2083373","3001665800","3002445546",[72,52,53,73,74,75,54,56,58,59,76,61,60,62,63,65,77,78,68,79,80],"1424263","3010162973","2031962","9614654","1649914","2029275","3006234743","9615745","1649518","Y","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:48.882786+00:00",0,null,31,95,[],[92,101,110,119,127,135,143,151,159,166],{"medical_device_id":93,"generic_name":94,"class_classification":95,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},3702,"導涙チューブ","Ⅰ","17003000",0.263158,0.106719,0.669097,0.0312576,{"medical_device_id":102,"generic_name":103,"class_classification":104,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},2135,"涙液・涙道シリコーンチューブ","Ⅱ","70337102",0.183333,0.249221,0.741632,0.0308862,{"medical_device_id":111,"generic_name":112,"class_classification":113,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":118},441,"ヘパリン使用涙液・涙道シリコーンチューブ","Ⅲ","70337203",0.146667,0.364286,0.719442,0.029116,{"medical_device_id":120,"generic_name":121,"class_classification":113,"jmdn_code":122,"name_similarity":123,"definition_similarity":124,"vector_similarity":125,"score":126},828,"腹膜灌流液注排用チューブ及び関連用具セット","70591000",0.158537,0.188925,0.6612,0.0263338,{"medical_device_id":128,"generic_name":129,"class_classification":95,"jmdn_code":130,"name_similarity":131,"definition_similarity":132,"vector_similarity":133,"score":134},4283,"挿管用喉頭鏡","70948009",0.288889,0.220049,0.627708,0.0163934,{"medical_device_id":136,"generic_name":137,"class_classification":104,"jmdn_code":138,"name_similarity":139,"definition_similarity":140,"vector_similarity":141,"score":142},1733,"硬性挿管用喉頭鏡","36706020",0.254902,0.197333,0.617429,0.016129,{"medical_device_id":144,"generic_name":145,"class_classification":113,"jmdn_code":146,"name_similarity":147,"definition_similarity":148,"vector_similarity":149,"score":150},562,"食道用ステント","36227000",0.122449,0.21028,0.689682,0.015873,{"medical_device_id":152,"generic_name":153,"class_classification":104,"jmdn_code":154,"name_similarity":155,"definition_similarity":156,"vector_similarity":157,"score":158},1662,"軟性挿管用喉頭鏡","36706010",0.240741,0.187135,0.619572,0.015625,{"medical_device_id":160,"generic_name":161,"class_classification":104,"jmdn_code":162,"name_similarity":163,"definition_similarity":164,"vector_similarity":165,"score":158},2118,"再使用可能な気管切開チューブ","38792000",0.0169492,0.190217,0.675708,{"medical_device_id":167,"generic_name":168,"class_classification":104,"jmdn_code":169,"name_similarity":170,"definition_similarity":171,"vector_similarity":172,"score":173},1699,"ビデオ硬性挿管用喉頭鏡","70123020",0.22807,0.191375,0.601551,0.0153846,[],{"510k":176,"classification":177,"enforcement":178,"event":179,"pma":180,"warning_letter":181},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":183,"definition_ja":184,"commentary_ja":185,"model_name":186,"source_hash":187,"reviewed_by":87,"reviewed_at":87,"created_at":188,"updated_at":188},"涙道ステント・挿管セット","涙道ステント及び挿管セットは、涙液排出系を修復することを意図している。涙道ステント及び挿管セットは、乳幼児及び成人における流涙症の治療；狭窄、閉塞又は裂傷等の涙小管病変；涙嚢鼻腔吻合術（従来法又はレーザー法）を要する状態；又は乳幼児における鼻涙管閉鎖の治療に適応されるが、これらに限定されない。","この製品は米国において明確なデバイスクラス（クラスI・II・III）が指定されていない未分類（Unclassified）の医療機器として扱われています。未分類機器であっても市販前届出（510(k)）による審査の対象となっており、既存の類似機器との実質的同等性を示すことで市販が認められる仕組みです。このように、リスクに基づくクラス分類が確定していない段階でも510(k)による審査経路が適用され得る点が、この製品区分の特徴です。","claude-sonnet-5","34e952a4be0a5c97fe45c3023f343269082cb98e97efd7775c7927017f8fe283","2026-08-24T02:21:53.785012+00:00",{"product_code":6,"summary_ja":190,"stats":191,"stats_hash":208,"model_name":186,"created_at":209,"updated_at":209},"510(k)の累計件数は31件で、19社が参入していますが、直近5年間の届出は確認されていません。不具合報告は累計約100件で、死亡報告はなく、Malfunction（不具合）が大半を占めており、主な問題としてPremature Separation（早期分離）、Material Rupture（材料破断）、Partial Blockage（部分閉塞）が挙げられています。回収については累計件数、クラスI・II・IIIいずれも確認されていません。",{"pma":192,"k510":193,"as_of":196,"events":197,"recalls":202,"top_problems":204},{"latest":87,"originals":86,"supplements":86},{"total":88,"last5y":86,"latest":194,"applicants":195},"2021-03-11",19,"2026-08",{"death":86,"other":86,"total":89,"injury":198,"last5y":199,"malfunction":200,"latest_month":201},14,6,81,"2026-01",{"total":86,"last5y":86,"latest":87,"class_i":86,"class_ii":86,"class_iii":86,"top_root_causes":203},[],[205,206,207],"Premature Separation","Material Rupture","Partial Blockage","a66e43064f696558288c96319136dc4fa2fdf5831e2bf6945450d016aeeb45a3","2026-08-24T05:03:24.690751+00:00",{"items":211,"total":86},[],{"items":213,"total":88},[214,220,223,228,232,237,241,245,249,253,257,261,265,268,271,274,277,282,285,288],{"k_number":32,"device_name":215,"applicant":216,"decision_date":194,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"Ritleng®+ and Ritleng®+ PVP","Fci (France Chirurgie Instrumentation) Sas","Traditional","SESE","Summary",{"k_number":19,"device_name":221,"applicant":216,"decision_date":222,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"LacriJet®","2020-12-18",{"k_number":30,"device_name":224,"applicant":225,"decision_date":226,"clearance_type":227,"decision_code":218,"statement_or_summary":219},"Lacriflow CL","Kaneka Pharma America, LLC","2017-04-18","Special",{"k_number":24,"device_name":229,"applicant":230,"decision_date":231,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"Nunchaku","Fci (France Chirurgie Instrumentation)","2016-11-03",{"k_number":29,"device_name":233,"applicant":234,"decision_date":235,"clearance_type":217,"decision_code":236,"statement_or_summary":219},"Oasis Lacrimal Intubation Set","Anodyne","2016-05-13","SESK",{"k_number":49,"device_name":238,"applicant":239,"decision_date":240,"clearance_type":227,"decision_code":218,"statement_or_summary":219},"DacryoCATH","Armadillo Biomedical, LLC","2015-01-12",{"k_number":34,"device_name":242,"applicant":243,"decision_date":244,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"STOPLOSS JONES TUBE","Ljt Surgical, Ltd.","2014-12-02",{"k_number":45,"device_name":246,"applicant":247,"decision_date":248,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"SELF-RETAINING BICANALICULUS INTUBATON SET II","Fci Sas (France Chirurgie Instrumentation)","2013-12-04",{"k_number":39,"device_name":250,"applicant":251,"decision_date":252,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"OPHTACATH KIT","France Chirurgae Instrumentation","2013-07-29",{"k_number":28,"device_name":254,"applicant":255,"decision_date":256,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"LACRIFAST","Hiroyasu Higuchi","2012-12-17",{"k_number":42,"device_name":258,"applicant":259,"decision_date":260,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"DCS LACRIMAL STENT","Dcs Surgical, Inc.","2012-11-08",{"k_number":41,"device_name":262,"applicant":263,"decision_date":264,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"LACRICATH LACRIMAL DUCT CATHETER","Quest Medical, Inc.","2012-10-19",{"k_number":33,"device_name":266,"applicant":239,"decision_date":267,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"DACRYOCATH","2012-08-31",{"k_number":43,"device_name":269,"applicant":247,"decision_date":270,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"CRAWFORD BIOCANALICULUS INTUBATION","2012-08-09",{"k_number":25,"device_name":272,"applicant":247,"decision_date":273,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"MASTERKA 40 MASTERKA 35 MASTERKA 30","2012-08-03",{"k_number":35,"device_name":275,"applicant":263,"decision_date":276,"clearance_type":227,"decision_code":218,"statement_or_summary":219},"STENTUBE LACRIMAL INTUBATION SET","2012-07-31",{"k_number":38,"device_name":278,"applicant":279,"decision_date":280,"clearance_type":217,"decision_code":218,"statement_or_summary":281},"MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE","Fci Ophthalmics, Inc.","2006-08-07","Statement",{"k_number":40,"device_name":283,"applicant":279,"decision_date":284,"clearance_type":217,"decision_code":218,"statement_or_summary":281},"SELF RETAINING BICANALICULUS INTUBATION SET","2004-11-18",{"k_number":26,"device_name":286,"applicant":279,"decision_date":287,"clearance_type":217,"decision_code":218,"statement_or_summary":281},"BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)","2003-09-17",{"k_number":48,"device_name":289,"applicant":290,"decision_date":291,"clearance_type":217,"decision_code":218,"statement_or_summary":219},"MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS","Eagle Vision, Inc.","2003-04-25",{"items":293,"total":86},[]]