[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KEP":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":107,"syncDates":270,"translation":277,"marketSummary":283,"recalls":296,"k510s":298,"pmas":313},{"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":15,"raw":16,"created_at":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":33},1041,"KEP","Media, Mounting, Oil Soluble","1","864.4010","PA","Pathology","4","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":29,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":18,"fei_number":22,"registration_number":26},[19,20,21],"K830659","K810323","K800847",[23,24,25],"1419341","3002806906","1419699",[23,27,25],"9610140","N","Y","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:48.225237+00:00",0,null,3,[],[38,46,54,60,68,74,81,87,94,100],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":33,"vector_similarity":44,"score":45},3981,"架台式手術用顕微鏡","Ⅰ","36354030",0.12766,0.56781,0.0240219,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":33,"vector_similarity":52,"score":53},178,"アルブミン使用接着剤","Ⅳ","33492204",0.0392157,0.606661,0.0163934,{"medical_device_id":55,"generic_name":56,"class_classification":41,"jmdn_code":57,"name_similarity":58,"definition_similarity":33,"vector_similarity":59,"score":53},3245,"壁取付け式X線管支持器","40947000",0.204082,0.528037,{"medical_device_id":61,"generic_name":62,"class_classification":63,"jmdn_code":64,"name_similarity":65,"definition_similarity":33,"vector_similarity":66,"score":67},1675,"軟性縦隔鏡","Ⅱ","70117000",0.186047,0.512815,0.016129,{"medical_device_id":69,"generic_name":70,"class_classification":63,"jmdn_code":71,"name_similarity":72,"definition_similarity":33,"vector_similarity":73,"score":67},2014,"造影用耐圧チューブ","70269000",0.0434783,0.604138,{"medical_device_id":75,"generic_name":76,"class_classification":49,"jmdn_code":77,"name_similarity":78,"definition_similarity":33,"vector_similarity":79,"score":80},174,"吸収性組織補強材","70434000",0.046875,0.602762,0.015873,{"medical_device_id":82,"generic_name":83,"class_classification":63,"jmdn_code":84,"name_similarity":85,"definition_similarity":33,"vector_similarity":86,"score":80},2168,"血液・薬液用加温コイル","70368000",0.173913,0.44593,{"medical_device_id":88,"generic_name":89,"class_classification":49,"jmdn_code":90,"name_similarity":91,"definition_similarity":33,"vector_similarity":92,"score":93},189,"コラーゲン使用軟組織注入材","70440000",0.0441176,0.601425,0.015625,{"medical_device_id":95,"generic_name":96,"class_classification":63,"jmdn_code":97,"name_similarity":98,"definition_similarity":33,"vector_similarity":99,"score":93},1708,"ビデオ軟性縦隔鏡","70134000",0.163265,0.518782,{"medical_device_id":101,"generic_name":102,"class_classification":41,"jmdn_code":103,"name_similarity":104,"definition_similarity":33,"vector_similarity":105,"score":106},3809,"成形型副木","36204000",0.162162,0.491372,0.0153846,[108,112,116,119,123,127,130,134,137,140,143,147,151,154,157,161,164,167,170,173,176,180,183,186,189,192,195,198,201,204,207,210,213,216,219,222,225,228,231,234,237,240,243,246,249,252,255,258,261,264,267],{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"PPM","General Purpose Reagent",16,{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"IFP","Formalin, Neutral Buffered",15,{"product_code":117,"device_name":118,"device_class":8,"k510_count":115},"KEM","Agent, Clearing",{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"KEO","Formulations, Paraffin, All",11,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"KDX","Solution, Decalcifier, Acid Containing",8,{"product_code":128,"device_name":129,"device_class":8,"k510_count":126},"LDZ","Fixative, Alcohol Containing",{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"IGG","Formaldehyde (Formalin, Formol)",7,{"product_code":135,"device_name":136,"device_class":8,"k510_count":133},"JCC","Ph Buffer",{"product_code":138,"device_name":139,"device_class":8,"k510_count":133},"JCE","Solution, Isotonic",{"product_code":141,"device_name":142,"device_class":8,"k510_count":133},"KEQ","Media, Mounting, Water Soluble",{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"LEB","Mounting Media",5,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"LDW","Fixative, Acid Containing",4,{"product_code":152,"device_name":153,"device_class":8,"k510_count":150},"LEA","Preservative, Cytological",{"product_code":155,"device_name":156,"device_class":8,"k510_count":35},"IGM","Solution, Carnoy'S",{"product_code":158,"device_name":159,"device_class":8,"k510_count":160},"IFH","Solution, Zenker'S",2,{"product_code":162,"device_name":163,"device_class":8,"k510_count":160},"IFQ","Formulations, Mercuric Chloride For Tissue",{"product_code":165,"device_name":166,"device_class":8,"k510_count":160},"IGC","Formalin-Saline",{"product_code":168,"device_name":169,"device_class":8,"k510_count":160},"IGE","Solution, Formalin Ammonium Bromide",{"product_code":171,"device_name":172,"device_class":8,"k510_count":160},"IGN","Fluid, Bouin'S",{"product_code":174,"device_name":175,"device_class":8,"k510_count":160},"KEL","Adhesive, Albumin-Based",{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"IER","Polyethylene Glycol (Carbowax)",1,{"product_code":181,"device_name":182,"device_class":8,"k510_count":179},"IFI","Sprays, Synthetic, Smear",{"product_code":184,"device_name":185,"device_class":8,"k510_count":179},"IFT","Glutaraldehyde",{"product_code":187,"device_name":188,"device_class":8,"k510_count":179},"IFZ","Gelatin For Specimen Adhesion",{"product_code":190,"device_name":191,"device_class":8,"k510_count":179},"IGB","Solution, Formalin-Sodium Acetate",{"product_code":193,"device_name":194,"device_class":8,"k510_count":179},"IGF","Solution, Formalin-Alcohol-Acetic Acid",{"product_code":196,"device_name":197,"device_class":8,"k510_count":179},"IJZ","Oil, Clearing",{"product_code":199,"device_name":200,"device_class":8,"k510_count":179},"LDX","Fixative, Metallic Containing",{"product_code":202,"device_name":203,"device_class":8,"k510_count":179},"LDY","Fixative, Formalin-Containing",{"product_code":205,"device_name":206,"device_class":8,"k510_count":33},"HZI","Acid, Osmic",{"product_code":208,"device_name":209,"device_class":8,"k510_count":33},"IAL","Iodine (Tincture)",{"product_code":211,"device_name":212,"device_class":8,"k510_count":33},"IAM","Solution, Lugol'S",{"product_code":214,"device_name":215,"device_class":8,"k510_count":33},"IAT","Syrup, Gum, Apathy'S",{"product_code":217,"device_name":218,"device_class":8,"k510_count":33},"IAW","Collodion",{"product_code":220,"device_name":221,"device_class":8,"k510_count":33},"IAY","Colchicine",{"product_code":223,"device_name":224,"device_class":8,"k510_count":33},"IBB","Phytohemaglutinin M",{"product_code":226,"device_name":227,"device_class":8,"k510_count":33},"IEX","Gelatin",{"product_code":229,"device_name":230,"device_class":8,"k510_count":33},"IEZ","Celloidin",{"product_code":232,"device_name":233,"device_class":8,"k510_count":33},"IFF","Solution, Decalcifier, Electrolytic",{"product_code":235,"device_name":236,"device_class":8,"k510_count":33},"IFJ","Fixative, Richardson Glycol",{"product_code":238,"device_name":239,"device_class":8,"k510_count":33},"IFL","Polyethylene Glycol Preservative",{"product_code":241,"device_name":242,"device_class":8,"k510_count":33},"IFN","Solution, Orth'S",{"product_code":244,"device_name":245,"device_class":8,"k510_count":33},"IFO","Solution, Newcomer'S",{"product_code":247,"device_name":248,"device_class":8,"k510_count":33},"IFS","Solution, Helly",{"product_code":250,"device_name":251,"device_class":8,"k510_count":33},"IFY","Gelatin-Formalin",{"product_code":253,"device_name":254,"device_class":8,"k510_count":33},"IGD","Solution, Formol Calcium",{"product_code":256,"device_name":257,"device_class":8,"k510_count":33},"IGK","Solution, Clarke'S",{"product_code":259,"device_name":260,"device_class":8,"k510_count":33},"JCB","Detergent",{"product_code":262,"device_name":263,"device_class":8,"k510_count":33},"KDY","Agent, Chelating For Decalcification",{"product_code":265,"device_name":266,"device_class":8,"k510_count":33},"KEE","Osmium Tetroxide",{"product_code":268,"device_name":269,"device_class":8,"k510_count":33},"KEF","Paraformaldehyde",{"510k":271,"classification":272,"enforcement":273,"event":274,"pma":275,"warning_letter":276},"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":278,"definition_ja":34,"commentary_ja":279,"model_name":280,"source_hash":281,"reviewed_by":34,"reviewed_at":34,"created_at":282,"updated_at":282},"油溶性封入剤","本品は、病理標本の顕微鏡観察用スライドを作製する際に、組織切片をカバーガラスとともに封入するために用いられる油溶性の封入剤です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分とされています。これは、この種の製品が人体へのリスクが低いと判断されているためです。","claude-sonnet-5","4e03bdf5e4d27acbb4542e804d58127816e1608a51a0f2bc01f1b7917d2c73a7","2026-08-24T02:07:08.607632+00:00",{"product_code":6,"summary_ja":284,"stats":285,"stats_hash":294,"model_name":280,"created_at":295,"updated_at":295},"本製品は届出免除区分であり、510(k)の累計件数は3件、参入企業数は3社となっていますが、直近5年間の届出は確認されていません。不具合報告および回収については、いずれも累計件数0件であり、報告や回収の実績は確認されていません。",{"pma":286,"k510":287,"as_of":289,"events":290,"recalls":291,"top_problems":293},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":33,"latest":288,"applicants":35},"1983-03-17","2026-08",{"death":33,"other":33,"total":33,"injury":33,"last5y":33,"malfunction":33,"latest_month":34},{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":292},[],[],"928325d9fb7d3853808fa197655ddc3c74436257e9ff74ec946e3d7a92815db9","2026-08-24T04:44:46.948226+00:00",{"items":297,"total":33},[],{"items":299,"total":35},[300,305,309],{"k_number":19,"device_name":301,"applicant":302,"decision_date":288,"clearance_type":303,"decision_code":304,"statement_or_summary":34},"CLEARIUM, MOUNTING MEDIUM","Surgipath Medical Industries, Inc.","Traditional","SESE",{"k_number":20,"device_name":306,"applicant":307,"decision_date":308,"clearance_type":303,"decision_code":304,"statement_or_summary":34},"ACRYTOL, MOUNTING MEDIUM","Surgipath","1981-03-06",{"k_number":21,"device_name":310,"applicant":311,"decision_date":312,"clearance_type":303,"decision_code":304,"statement_or_summary":34},"ENTELLAN","Mcb Manufacturing Chemists, Inc.","1980-05-08",{"items":314,"total":33},[]]