[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JYL":3},{"classification":4,"mappedDevices":162,"similarCandidates":163,"relatedClassifications":233,"syncDates":506},{"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":156,"updated_at":157,"recall_count":158,"latest_recall_date":159,"k510_count":160,"pma_count":158,"event_count":161},4314,"JYL","Hook, Microsurgical Ear","1","874.4420","EN","Ear, Nose, Throat","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":154,"product_code":6,"review_panel":10,"gmp_exempt_flag":154,"third_party_flag":154,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":154,"medical_specialty_description":11,"summary_malfunction_reporting":155},{"k_number":17,"fei_number":23,"registration_number":112},[18,19,20,21,22],"K822166","K822195","K834188","K780287","K772390",[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],"3005693456","3007583964","3022862651","3015451162","3002807072","3004028763","3003052153","2523865","3015895045","1317628","3013247477","3003249645","1000508235","3002858762","1720747","3002834291","1923569","3002750084","3008770252","3006554912","3004571672","3008936260","3002807798","3007648354","3007475226","1000136191","3002902165","3002786339","3001620590","1000160162","3009513193","3002808001","3015972835","6362","3004216008","3002806315","1926681","5870","3010034765","3010687973","3004608878","3008782585","3035678069","3002409980","3005969827","1000123297","3010041511","3003944071","3002935209","3014334038","3006509795","3002808335","1000113735","3036795921","3005440795","3005528784","1417592","3021680161","3010726901","1000525271","3004001706","3005809810","1000402972","2434839","3546","3008902714","3010455030","3029082594","3014342096","3002808268","3023657851","3003418325","3004215117","3007290840","1421101","3003499455","1000119305","3002807464","2916714","2020550","1000115048","3011050570","3016965929","3013497507","3012507533","3035708926","3005747797","1000140363",[25,26,27,113,114,32,115,34,116,37,38,39,40,117,118,119,42,120,43,121,44,45,122,47,123,124,125,52,126,54,127,56,128,129,130,60,131,63,64,132,66,70,73,133,77,134,78,135,79,80,81,82,84,85,136,87,137,89,138,90,139,91,92,140,94,141,95,96,142,143,98,144,145,102,103,146,105,147,106,107,148,149,108,109,150,151,152,153],"8010099","9617426","9616246","8010851","1057946","9680515","1123010","9610773","9610612","1056350","3007507973","9611503","9613926","1932180","1052728","9680837","8040278","9710524","2431166","9615857","8010374","1313525","1836161","3011137372","9610905","8010372","1421879","8040233","1646747","2249529","3010202439","2529846","9681622","8030607","9611112","9611102","9610617","3005067367","9612074","8044098","1424478","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",0,null,5,8,[],[164,172,179,186,192,200,206,214,220,227],{"medical_device_id":165,"generic_name":166,"class_classification":167,"jmdn_code":168,"name_similarity":169,"definition_similarity":158,"vector_similarity":170,"score":171},4296,"耳鼻科手術用プローブ","Ⅰ","33433000",0.235294,0.659132,0.0285948,{"medical_device_id":173,"generic_name":174,"class_classification":167,"jmdn_code":175,"name_similarity":176,"definition_similarity":158,"vector_similarity":177,"score":178},3779,"外科用テープ","70419000",0.233333,0.658455,0.0278261,{"medical_device_id":180,"generic_name":181,"class_classification":167,"jmdn_code":182,"name_similarity":183,"definition_similarity":158,"vector_similarity":184,"score":185},3977,"手術用顕微鏡","36354010",0.433333,0.534402,0.0163934,{"medical_device_id":187,"generic_name":188,"class_classification":167,"jmdn_code":189,"name_similarity":190,"definition_similarity":158,"vector_similarity":191,"score":185},4170,"耳用ナイフ","12245000",0.137931,0.702858,{"medical_device_id":193,"generic_name":194,"class_classification":195,"jmdn_code":196,"name_similarity":197,"definition_similarity":158,"vector_similarity":198,"score":199},2870,"単回使用眼科用鈎","Ⅱ","35314002",0.136364,0.694268,0.016129,{"medical_device_id":201,"generic_name":202,"class_classification":167,"jmdn_code":203,"name_similarity":204,"definition_similarity":158,"vector_similarity":205,"score":199},3981,"架台式手術用顕微鏡","36354030",0.351351,0.59302,{"medical_device_id":207,"generic_name":208,"class_classification":209,"jmdn_code":210,"name_similarity":211,"definition_similarity":158,"vector_similarity":212,"score":213},947,"マイクロ波メス","Ⅲ","70650000",0.342857,0.550553,0.015873,{"medical_device_id":215,"generic_name":216,"class_classification":167,"jmdn_code":217,"name_similarity":218,"definition_similarity":158,"vector_similarity":219,"score":213},4267,"眼科用鈎","32767000",0.142857,0.682408,{"medical_device_id":221,"generic_name":222,"class_classification":195,"jmdn_code":223,"name_similarity":224,"definition_similarity":158,"vector_similarity":225,"score":226},2052,"耳管用カテーテル","10718000",0.0217391,0.678844,0.015625,{"medical_device_id":228,"generic_name":229,"class_classification":167,"jmdn_code":230,"name_similarity":231,"definition_similarity":158,"vector_similarity":232,"score":226},3978,"可搬型手術用顕微鏡","36354020",0.295455,0.530905,[234,238,242,246,250,253,256,259,262,265,268,272,275,278,281,285,288,291,294,297,300,303,307,310,313,316,319,322,326,329,332,335,338,341,344,347,350,353,356,359,362,365,368,371,374,377,380,383,386,389,392,395,398,401,404,407,410,413,416,419,422,425,428,431,434,437,440,443,446,449,452,455,458,461,464,467,470,473,476,479,482,485,488,491,494,497,500,503],{"product_code":235,"device_name":236,"device_class":8,"k510_count":237},"LRC","Instrument, Ent Manual Surgical",65,{"product_code":239,"device_name":240,"device_class":8,"k510_count":241},"KAE","Forceps, Ent",14,{"product_code":243,"device_name":244,"device_class":8,"k510_count":245},"KAI","Mirror, Ent",9,{"product_code":247,"device_name":248,"device_class":8,"k510_count":249},"JYG","Curette, Ear",7,{"product_code":251,"device_name":252,"device_class":8,"k510_count":249},"JYO","Knife, Ear",{"product_code":254,"device_name":255,"device_class":8,"k510_count":160},"JYJ","Gauge, Measuring",{"product_code":257,"device_name":258,"device_class":8,"k510_count":160},"JZF","Tube, Ear Suction",{"product_code":260,"device_name":261,"device_class":8,"k510_count":160},"KAD","Elevator, Ent",{"product_code":263,"device_name":264,"device_class":8,"k510_count":160},"KAL","Retractor, Ent",{"product_code":266,"device_name":267,"device_class":8,"k510_count":160},"KTG","Knife, Ent",{"product_code":269,"device_name":270,"device_class":8,"k510_count":271},"JYM","Inserter, Myringotomy Tube",4,{"product_code":273,"device_name":274,"device_class":8,"k510_count":271},"JZB","Scissors, Ear",{"product_code":276,"device_name":277,"device_class":8,"k510_count":271},"KAC","Tube, Laryngectomy",{"product_code":279,"device_name":280,"device_class":8,"k510_count":271},"KBC","Saw, Nasal",{"product_code":282,"device_name":283,"device_class":8,"k510_count":284},"JYS","Perforator, Ear-Lobe",3,{"product_code":286,"device_name":287,"device_class":8,"k510_count":284},"KAR","Irrigator, Sinus",{"product_code":289,"device_name":290,"device_class":8,"k510_count":284},"KBD","Scissors, Nasal",{"product_code":292,"device_name":293,"device_class":8,"k510_count":284},"KBG","Trocar, Sinus",{"product_code":295,"device_name":296,"device_class":8,"k510_count":284},"KBN","Gag, Mouth",{"product_code":298,"device_name":299,"device_class":8,"k510_count":284},"KCD","Bougie, Esophageal, Ent",{"product_code":301,"device_name":302,"device_class":8,"k510_count":284},"KCF","Dilator, Esophageal, Ent",{"product_code":304,"device_name":305,"device_class":8,"k510_count":306},"EWQ","Saw, Surgical, Ent (Electric Or Pneumatic)",2,{"product_code":308,"device_name":309,"device_class":8,"k510_count":306},"JYQ","Loop, Wire",{"product_code":311,"device_name":312,"device_class":8,"k510_count":306},"JYR","Nipper, Malleus",{"product_code":314,"device_name":315,"device_class":8,"k510_count":306},"JYT","Pick, Microsurgical Ear",{"product_code":317,"device_name":318,"device_class":8,"k510_count":306},"JZD","Snare, Ear",{"product_code":320,"device_name":321,"device_class":8,"k510_count":306},"LJW","Tracheotome",{"product_code":323,"device_name":324,"device_class":8,"k510_count":325},"JYE","Chisel, Middle-Ear",1,{"product_code":327,"device_name":328,"device_class":8,"k510_count":325},"JYP","Knife, Myringotomy",{"product_code":330,"device_name":331,"device_class":8,"k510_count":325},"JYW","Press, Vein",{"product_code":333,"device_name":334,"device_class":8,"k510_count":325},"JYY","Rasp, Ear",{"product_code":336,"device_name":337,"device_class":8,"k510_count":325},"JYZ","Rod, Measuring Ear",{"product_code":339,"device_name":340,"device_class":8,"k510_count":325},"JZA","Rongeur, Mastoid",{"product_code":342,"device_name":343,"device_class":8,"k510_count":325},"JZE","Spoon, Ear",{"product_code":345,"device_name":346,"device_class":8,"k510_count":325},"KAB","Trocar, Laryngeal",{"product_code":348,"device_name":349,"device_class":8,"k510_count":325},"KAK","Probe, Ent",{"product_code":351,"device_name":352,"device_class":8,"k510_count":325},"KAP","Curette, Nasal",{"product_code":354,"device_name":355,"device_class":8,"k510_count":325},"KAS","Knife, Nasal",{"product_code":357,"device_name":358,"device_class":8,"k510_count":325},"KBF","Trephine, Sinus",{"product_code":360,"device_name":361,"device_class":8,"k510_count":325},"KBH","Adenotome",{"product_code":363,"device_name":364,"device_class":8,"k510_count":325},"KBJ","Curette, Adenoid",{"product_code":366,"device_name":367,"device_class":8,"k510_count":325},"KBL","Depressor, Metal Tongue, Surgical",{"product_code":369,"device_name":370,"device_class":8,"k510_count":325},"KBM","Dissector, Tonsil",{"product_code":372,"device_name":373,"device_class":8,"k510_count":325},"KBO","Guillotine, Tonsil",{"product_code":375,"device_name":376,"device_class":8,"k510_count":325},"KBQ","Knife, Tonsil",{"product_code":378,"device_name":379,"device_class":8,"k510_count":325},"KBW","Screw, Oral",{"product_code":381,"device_name":382,"device_class":8,"k510_count":325},"KBZ","Snare, Tonsil",{"product_code":384,"device_name":385,"device_class":8,"k510_count":325},"KCA","Tonsillectome",{"product_code":387,"device_name":388,"device_class":8,"k510_count":325},"KCB","Tube, Tonsil Suction",{"product_code":390,"device_name":391,"device_class":8,"k510_count":325},"KCG","Dilator, Tracheal",{"product_code":393,"device_name":394,"device_class":8,"k510_count":325},"KTE","Trocar, Ent",{"product_code":396,"device_name":397,"device_class":8,"k510_count":325},"MMO","Tray, Surgical, Ent",{"product_code":399,"device_name":400,"device_class":8,"k510_count":325},"QGK","Balloon, Nasal Airway",{"product_code":402,"device_name":403,"device_class":8,"k510_count":325},"SBS","Laryngeal Injection Set With Led Light",{"product_code":405,"device_name":406,"device_class":8,"k510_count":158},"JYF","Clamp, Ossicle Holding",{"product_code":408,"device_name":409,"device_class":8,"k510_count":158},"JYH","Excavator, Ear",{"product_code":411,"device_name":412,"device_class":8,"k510_count":158},"JYI","Gauge, Mastoid",{"product_code":414,"device_name":415,"device_class":8,"k510_count":158},"JYN","Inserter, Sacculotomy Tack",{"product_code":417,"device_name":418,"device_class":8,"k510_count":158},"JYX","Punch, Attic",{"product_code":420,"device_name":421,"device_class":8,"k510_count":158},"JZC","Searcher, Mastoid",{"product_code":423,"device_name":424,"device_class":8,"k510_count":158},"JZY","Knife, Laryngeal",{"product_code":426,"device_name":427,"device_class":8,"k510_count":158},"JZZ","Saw, Laryngeal",{"product_code":429,"device_name":430,"device_class":8,"k510_count":158},"KAA","Set, Laryngeal Injection",{"product_code":432,"device_name":433,"device_class":8,"k510_count":158},"KAH","Microrule, Ent",{"product_code":435,"device_name":436,"device_class":8,"k510_count":158},"KAJ","Mobilizer, Ent",{"product_code":438,"device_name":439,"device_class":8,"k510_count":158},"KAO","Curette, Ethmoid",{"product_code":441,"device_name":442,"device_class":8,"k510_count":158},"KAQ","Gouge, Nasal, Ent",{"product_code":444,"device_name":445,"device_class":8,"k510_count":158},"KAT","Perforator, Antrum",{"product_code":447,"device_name":448,"device_class":8,"k510_count":158},"KAW","Punch, Antrum",{"product_code":450,"device_name":451,"device_class":8,"k510_count":158},"KAX","Punch, Ethmoid",{"product_code":453,"device_name":454,"device_class":8,"k510_count":158},"KAY","Punch, Nasal",{"product_code":456,"device_name":457,"device_class":8,"k510_count":158},"KAZ","Rasp, Frontal-Sinus",{"product_code":459,"device_name":460,"device_class":8,"k510_count":158},"KBA","Rasp, Nasal",{"product_code":462,"device_name":463,"device_class":8,"k510_count":158},"KBB","Rongeur, Nasal",{"product_code":465,"device_name":466,"device_class":8,"k510_count":158},"KBE","Snare, Nasal",{"product_code":468,"device_name":469,"device_class":8,"k510_count":158},"KBK","Curette, Salpingeal",{"product_code":471,"device_name":472,"device_class":8,"k510_count":158},"KBP","Hook, Tonsil Suturing",{"product_code":474,"device_name":475,"device_class":8,"k510_count":158},"KBR","Needle, Tonsil Suturing",{"product_code":477,"device_name":478,"device_class":8,"k510_count":158},"KBS","Punch, Adenoid",{"product_code":480,"device_name":481,"device_class":8,"k510_count":158},"KBT","Punch, Tonsil",{"product_code":483,"device_name":484,"device_class":8,"k510_count":158},"KBX","Screw, Tonsil",{"product_code":486,"device_name":487,"device_class":8,"k510_count":158},"KCC","Bistoury, Tracheal",{"product_code":489,"device_name":490,"device_class":8,"k510_count":158},"KCH","Hook, Tracheal",{"product_code":492,"device_name":493,"device_class":8,"k510_count":158},"KCI","Trocar, Tracheal",{"product_code":495,"device_name":496,"device_class":8,"k510_count":158},"KTF","Punch, Ent",{"product_code":498,"device_name":499,"device_class":8,"k510_count":158},"NLB","Trocar, Tracheal, Laryngeal, Sinus, Reprocessed",{"product_code":501,"device_name":502,"device_class":8,"k510_count":158},"OGR","Ear, Nose, And Throat Surgical Tray",{"product_code":504,"device_name":505,"device_class":8,"k510_count":158},"OGU","Pierced Ear\u002FEntry Cleaning Tray",{"510k":507,"classification":508,"enforcement":509,"event":510,"pma":511,"warning_letter":512},"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"]