[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HNA":3},{"classification":4,"mappedDevices":150,"similarCandidates":151,"relatedClassifications":220,"syncDates":340,"translation":347,"marketSummary":353,"recalls":367,"k510s":369,"pmas":381},{"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":144,"updated_at":145,"recall_count":146,"latest_recall_date":147,"k510_count":148,"pma_count":146,"event_count":149},677,"HNA","Spud, Ophthalmic","1","886.4350","OP","Ophthalmic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":142,"product_code":6,"review_panel":10,"gmp_exempt_flag":142,"third_party_flag":142,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":142,"medical_specialty_description":11,"summary_malfunction_reporting":143},{"k_number":17,"fei_number":20,"registration_number":112},[18,19],"K931449","K874963",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111],"6749","3013576617","3043355002","3007583964","3015177648","3002675176","1211998","3004028763","3004892425","3003772581","3000215273","3003951061","1000138054","3009465247","1317628","3015972897","3003553186","1000160574","6750","3008797953","1720747","3002834291","1923569","3002808441","3002445546","3002750084","3008770252","3006677911","3006554912","3009027787","3004571672","3008936260","3007648354","1000136191","3002786339","1000160162","3003408840","3003860739","1000347621","6362","1000307733","3004216008","3010687973","1000109483","3012733432","3008782585","2518410","3013358456","1000246164","3000280067","3010041511","3009504366","3010399422","3014334038","3002806755","1039131","3012226300","3042940336","3006550126","3003860763","3005528784","3011110913","1417592","3016069968","3005809810","3007334784","3031231776","2434839","3008338766","3003435550","3004475955","3012185136","1045379","3008754084","3008342610","3003039352","1935627","3003418325","3004215117","3001180016","1421101","3006380247","1000119305","2916714","2242450","1000115048","3003032798","3013503739","3005747797","1000140363","3030451558",[113,22,23,114,115,24,116,25,117,26,27,29,118,32,34,36,37,119,120,40,41,42,43,47,48,49,50,51,52,121,53,122,58,123,63,65,67,68,71,72,124,73,74,125,126,127,76,77,128,78,129,130,79,80,131,81,82,83,84,85,86,132,87,88,89,90,91,92,93,133,94,134,135,95,96,97,98,99,136,101,137,138,102,104,105,139,107,140,108,141,111],"9617768","9611502","8043752","1319639","8040381","9680620","8010851","1934420","1056350","1932180","8040278","3007597038","1058726","8040382","9616245","9680718","1313525","1836161","9616250","3011137372","1421879","2085143","1646747","2249529","2031962","2529846","1423662","9611112","8044098","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:47.808424+00:00",0,null,2,1,[],[152,160,166,173,181,187,193,200,207,214],{"medical_device_id":153,"generic_name":154,"class_classification":155,"jmdn_code":156,"name_similarity":157,"definition_similarity":146,"vector_similarity":158,"score":159},4178,"眼科用ナイフ","Ⅰ","32764001",0.5,0.705111,0.032002,{"medical_device_id":161,"generic_name":162,"class_classification":155,"jmdn_code":163,"name_similarity":157,"definition_similarity":146,"vector_similarity":164,"score":165},4186,"眼科用せん刀","35327001",0.688737,0.0312576,{"medical_device_id":167,"generic_name":168,"class_classification":155,"jmdn_code":169,"name_similarity":170,"definition_similarity":146,"vector_similarity":171,"score":172},3757,"眼科用縫合針","32763000",0.413793,0.677735,0.0285425,{"medical_device_id":174,"generic_name":175,"class_classification":176,"jmdn_code":177,"name_similarity":178,"definition_similarity":146,"vector_similarity":179,"score":180},1836,"眼科用針","Ⅱ","70200000",0.478261,0.663702,0.0280392,{"medical_device_id":182,"generic_name":183,"class_classification":155,"jmdn_code":184,"name_similarity":178,"definition_similarity":146,"vector_similarity":185,"score":186},3901,"眼科用鏡","32707000",0.660203,0.0277459,{"medical_device_id":188,"generic_name":189,"class_classification":155,"jmdn_code":190,"name_similarity":157,"definition_similarity":146,"vector_similarity":191,"score":192},4244,"眼科用消息子","35251000",0.656714,0.0276732,{"medical_device_id":194,"generic_name":195,"class_classification":176,"jmdn_code":196,"name_similarity":197,"definition_similarity":146,"vector_similarity":198,"score":199},2269,"眼内空気置換装置","37069000",0.392857,0.671024,0.0275264,{"medical_device_id":201,"generic_name":202,"class_classification":155,"jmdn_code":203,"name_similarity":204,"definition_similarity":146,"vector_similarity":205,"score":206},4179,"水晶体嚢切開刀","34984000",0.423077,0.662152,0.0268565,{"medical_device_id":208,"generic_name":209,"class_classification":176,"jmdn_code":210,"name_similarity":211,"definition_similarity":146,"vector_similarity":212,"score":213},2842,"単回使用眼科用ナイフ","32764002",0.375,0.665942,0.0261327,{"medical_device_id":215,"generic_name":216,"class_classification":176,"jmdn_code":217,"name_similarity":204,"definition_similarity":146,"vector_similarity":218,"score":219},1765,"眼科用内視鏡","70156000",0.658608,0.0260135,[221,225,229,233,237,241,245,249,253,256,260,263,267,271,274,277,280,283,286,289,292,295,298,301,304,307,310,313,316,319,322,325,328,331,334,337],{"product_code":222,"device_name":223,"device_class":8,"k510_count":224},"HMX","Cannula, Ophthalmic",77,{"product_code":226,"device_name":227,"device_class":8,"k510_count":228},"HNN","Knife, Ophthalmic",54,{"product_code":230,"device_name":231,"device_class":8,"k510_count":232},"HNR","Forceps, Ophthalmic",44,{"product_code":234,"device_name":235,"device_class":8,"k510_count":236},"HNY","Cystotome",20,{"product_code":238,"device_name":239,"device_class":8,"k510_count":240},"HNF","Scissors, Ophthalmic",15,{"product_code":242,"device_name":243,"device_class":8,"k510_count":244},"HRH","Trephine, Manual, Ophthalmic",12,{"product_code":246,"device_name":247,"device_class":8,"k510_count":248},"HNC","Specula, Ophthalmic",11,{"product_code":250,"device_name":251,"device_class":8,"k510_count":252},"HNL","Probe, Lachrymal",10,{"product_code":254,"device_name":255,"device_class":8,"k510_count":252},"HNQ","Hook, Ophthalmic",{"product_code":257,"device_name":258,"device_class":8,"k510_count":259},"HNH","Ring, Ophthalmic (Flieringa)",7,{"product_code":261,"device_name":262,"device_class":8,"k510_count":259},"HOE","Caliper, Ophthalmic",{"product_code":264,"device_name":265,"device_class":8,"k510_count":266},"HND","Spatula, Ophthalmic",6,{"product_code":268,"device_name":269,"device_class":8,"k510_count":270},"HNJ","Punch, Corneo-Scleral",3,{"product_code":272,"device_name":273,"device_class":8,"k510_count":270},"HNW","Dilator, Lachrymal",{"product_code":275,"device_name":276,"device_class":8,"k510_count":270},"HOB","Clamp, Muscle, Ophthalmic",{"product_code":278,"device_name":279,"device_class":8,"k510_count":270},"HOD","Clamp, Eyelid, Ophthalmic",{"product_code":281,"device_name":282,"device_class":8,"k510_count":148},"HNI","Retractor, Ophthalmic",{"product_code":284,"device_name":285,"device_class":8,"k510_count":148},"HNM","Needle, Ophthalmic Suturing",{"product_code":287,"device_name":288,"device_class":8,"k510_count":148},"HNX","Depressor, Orbital",{"product_code":290,"device_name":291,"device_class":8,"k510_count":148},"HNZ","Curette, Ophthalmic",{"product_code":293,"device_name":294,"device_class":8,"k510_count":148},"HOC","Clip, Iris Retractor",{"product_code":296,"device_name":297,"device_class":8,"k510_count":149},"HOF","Burr, Corneal, Manual",{"product_code":299,"device_name":300,"device_class":8,"k510_count":149},"NGY","Cannula, Trocar, Ophthalmic",{"product_code":302,"device_name":303,"device_class":8,"k510_count":146},"HMZ","Trabeculotome",{"product_code":305,"device_name":306,"device_class":8,"k510_count":146},"HNB","Spoon, Ophthalmic",{"product_code":308,"device_name":309,"device_class":8,"k510_count":146},"HNE","Snare, Enucleating",{"product_code":311,"device_name":312,"device_class":8,"k510_count":146},"HNG","Rongeur, Lachrymal Sac",{"product_code":314,"device_name":315,"device_class":8,"k510_count":146},"HNK","Probe, Trabeculotomy",{"product_code":317,"device_name":318,"device_class":8,"k510_count":146},"HNP","Introducer, Sphere",{"product_code":320,"device_name":321,"device_class":8,"k510_count":146},"HNS","Expressor",{"product_code":323,"device_name":324,"device_class":8,"k510_count":146},"HNT","Erisophake",{"product_code":326,"device_name":327,"device_class":8,"k510_count":146},"HOA","Compressor, Orbital",{"product_code":329,"device_name":330,"device_class":8,"k510_count":146},"MXY","Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal",{"product_code":332,"device_name":333,"device_class":8,"k510_count":146},"NLA","Knife, Ophthalmic, Reprocessed",{"product_code":335,"device_name":336,"device_class":8,"k510_count":146},"PZG","Surgical Eye Tray",{"product_code":338,"device_name":339,"device_class":8,"k510_count":146},"QDV","Iol Tray",{"510k":341,"classification":342,"enforcement":343,"event":344,"pma":345,"warning_letter":346},"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":348,"definition_ja":147,"commentary_ja":349,"model_name":350,"source_hash":351,"reviewed_by":147,"reviewed_at":147,"created_at":352,"updated_at":352},"眼科用スパッド","本品は眼科手術において異物除去などに用いられる器具です。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。","claude-sonnet-5","9228e7b779092c6004c2a39b0095cd2d7ed6bec961fbee8008588b4b4fd32969","2026-08-24T01:56:53.662172+00:00",{"product_code":6,"summary_ja":354,"stats":355,"stats_hash":365,"model_name":350,"created_at":366,"updated_at":366},"本製品は届出免除（510(k) Exempt）の区分ですが、510(k)としての届出は累計2件、参入企業数は2社であり、直近5年間の届出はなく、最新の判定は1993年8月となっています。不具合報告（MDR）は累計1件で、内容は不具合（Malfunction）によるもので、死亡・傷害の報告は確認されていません。直近5年間の不具合報告はなく、最新の報告は2010年7月です。回収（リコール）については累計件数が0件で、クラスI・II・IIIいずれの実施も確認されていません。",{"pma":356,"k510":357,"as_of":359,"events":360,"recalls":362,"top_problems":364},{"latest":147,"originals":146,"supplements":146},{"total":148,"last5y":146,"latest":358,"applicants":148},"1993-08-31","2026-08",{"death":146,"other":146,"total":149,"injury":146,"last5y":146,"malfunction":149,"latest_month":361},"2010-07",{"total":146,"last5y":146,"latest":147,"class_i":146,"class_ii":146,"class_iii":146,"top_root_causes":363},[],[],"3d0680f6a8dd08f5eb56bf3c5af6f300515ab22185faae1866b6bd77bd6ec3c1","2026-08-24T04:32:35.506862+00:00",{"items":368,"total":146},[],{"items":370,"total":148},[371,377],{"k_number":18,"device_name":372,"applicant":373,"decision_date":358,"clearance_type":374,"decision_code":375,"statement_or_summary":376},"MSP OPHTHALMIC (EYE SPUD)","Medical Sterile Products, Inc.","Traditional","SESE","Statement",{"k_number":19,"device_name":378,"applicant":379,"decision_date":380,"clearance_type":374,"decision_code":375,"statement_or_summary":147},"MANUAL OPHTHALMIC SURGICAL INSTRUMENTS","Solway, Inc.","1987-12-23",{"items":382,"total":146},[]]