[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KAL":3},{"classification":4,"mappedDevices":216,"similarCandidates":217,"relatedClassifications":289,"syncDates":561},{"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":209,"updated_at":210,"recall_count":211,"latest_recall_date":212,"k510_count":213,"pma_count":214,"event_count":215},395,"KAL","Retractor, Ent","1","874.4420","EN","Ear, Nose, Throat","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":207,"product_code":6,"review_panel":10,"gmp_exempt_flag":207,"third_party_flag":207,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":207,"medical_specialty_description":11,"summary_malfunction_reporting":208},{"k_number":17,"fei_number":23,"registration_number":146},[18,19,20,21,22],"K760851","K772392","K870758","K833604","K772381",[13,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145],"3043355002","3005693456","3005349543","3015451162","3006154292","3004545991","3002675176","3002808360","3004028763","3003772581","3003052153","1000022662","3003431869","3009865268","1317628","3013247477","3003249645","3006806650","3008797953","1000405819","1720747","3010829427","3002834291","1923569","3007137643","1000307813","3002750084","3002806575","3008770252","3006554912","1000168975","3002807798","3007648354","3000183921","3016170849","3007475226","1000136191","3002902165","3011371465","3009513193","3015972835","1937310","3008238512","6362","3004216008","3002806315","1926681","5870","3010034765","3004608878","3010687973","3008782585","3032747418","3002807421","3002409980","3013358456","3005969827","3000280067","3010041511","3003944071","1000453845","3021666757","3014334038","3002631959","1000124817","3002808270","1032347","4476","3006509795","3002807091","3036795921","3005440795","3009718267","3010055973","3005528784","1417592","3021680161","3010726901","1000525271","3002855321","3004001706","3005809810","1000402972","2434839","3008338766","3002631673","3546","3003435550","3008902714","3002808043","3010455030","3010699884","1315756","3014342096","3002808268","1000117045","3023657851","3001595398","3003418325","5906","3004215117","3002809480","3007290840","3007773213","1421101","3003200061","3002807754","4442","3003499455","1000119305","3001417518","3002807464","2916714","2020550","1000115048","3016965929","3013497507","3002808264","3012507533","3008268830","3005747797","1000140363",[13,24,147,27,28,30,148,149,150,151,152,36,37,153,39,154,41,42,44,45,46,47,155,156,48,157,158,52,159,53,160,161,162,163,56,164,58,165,62,166,63,64,167,65,168,169,170,171,70,73,74,76,172,79,82,85,86,173,174,89,90,175,176,94,177,178,95,179,180,181,96,97,98,182,183,99,100,101,184,104,105,185,107,108,186,111,112,187,188,114,189,190,191,115,116,117,192,193,120,121,122,123,124,194,195,127,128,196,197,198,136,137,199,200,201,139,140,202,203,142,204,205,206],"2084346","9611278","8010528","8010099","8010422","9614062","9616246","8010851","1057946","9680515","8010733","3008132398","9610773","8010405","9610612","9611262","1056350","3007507973","9613926","1932180","9680837","8043467","8040278","9611274","9710524","9615857","9611827","8010374","9680718","9612086","9612075","1313525","9614069","1836161","1932214","9613083","9616250","8010155","3011137372","9610905","1057421","8010372","8010704","1421879","8010343","8010665","8040233","8010547","3010202439","2529846","9680519","8010168","8030607","2248180","9611112","8010433","9610617","3005067367","8044098","1424478","N","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-18T22:05:38.961415+00:00",1,"2023-07-12",5,0,15,[],[218,226,233,240,247,254,261,267,274,281],{"medical_device_id":219,"generic_name":220,"class_classification":221,"jmdn_code":222,"name_similarity":223,"definition_similarity":214,"vector_similarity":224,"score":225},4274,"歯科用開創器","Ⅰ","13380000",0.55,0.786174,0.0327869,{"medical_device_id":227,"generic_name":228,"class_classification":221,"jmdn_code":229,"name_similarity":230,"definition_similarity":214,"vector_similarity":231,"score":232},4273,"開創器","13373001",0.47619,0.742244,0.032002,{"medical_device_id":234,"generic_name":235,"class_classification":221,"jmdn_code":236,"name_similarity":237,"definition_similarity":214,"vector_similarity":238,"score":239},4284,"歯科用開口器","70949000",0.434783,0.735637,0.03125,{"medical_device_id":241,"generic_name":242,"class_classification":221,"jmdn_code":243,"name_similarity":244,"definition_similarity":214,"vector_similarity":245,"score":246},4270,"眼科用開創器","70943000",0.4,0.749206,0.0308349,{"medical_device_id":248,"generic_name":249,"class_classification":250,"jmdn_code":251,"name_similarity":244,"definition_similarity":214,"vector_similarity":252,"score":253},2874,"単回使用開創器","Ⅱ","13373002",0.71916,0.0305361,{"medical_device_id":255,"generic_name":256,"class_classification":221,"jmdn_code":257,"name_similarity":258,"definition_similarity":214,"vector_similarity":259,"score":260},4269,"眼窩固定鈎","35314001",0.454545,0.666413,0.0301587,{"medical_device_id":262,"generic_name":263,"class_classification":221,"jmdn_code":264,"name_similarity":244,"definition_similarity":214,"vector_similarity":265,"score":266},4275,"泌尿器科用開創器","35311000",0.709328,0.0298507,{"medical_device_id":268,"generic_name":269,"class_classification":221,"jmdn_code":270,"name_similarity":271,"definition_similarity":214,"vector_similarity":272,"score":273},4265,"眼球固定鈎","13381001",0.37037,0.70984,0.0296443,{"medical_device_id":275,"generic_name":276,"class_classification":250,"jmdn_code":277,"name_similarity":278,"definition_similarity":214,"vector_similarity":279,"score":280},2871,"単回使用眼球固定鈎","13381002",0.322581,0.680446,0.0289916,{"medical_device_id":282,"generic_name":283,"class_classification":284,"jmdn_code":285,"name_similarity":286,"definition_similarity":214,"vector_similarity":287,"score":288},1148,"植込み型前立腺組織牽引システム","Ⅲ","58882003",0.2,0.6668,0.025987,[290,294,298,302,306,309,312,315,318,321,324,328,331,334,337,341,344,347,350,353,356,359,363,366,369,372,375,378,381,384,387,390,393,396,399,402,405,408,411,414,417,420,423,426,429,432,435,438,441,444,447,450,453,456,459,462,465,468,471,474,477,480,483,486,489,492,495,498,501,504,507,510,513,516,519,522,525,528,531,534,537,540,543,546,549,552,555,558],{"product_code":291,"device_name":292,"device_class":8,"k510_count":293},"LRC","Instrument, Ent Manual Surgical",65,{"product_code":295,"device_name":296,"device_class":8,"k510_count":297},"KAE","Forceps, Ent",14,{"product_code":299,"device_name":300,"device_class":8,"k510_count":301},"KAI","Mirror, Ent",9,{"product_code":303,"device_name":304,"device_class":8,"k510_count":305},"JYG","Curette, Ear",7,{"product_code":307,"device_name":308,"device_class":8,"k510_count":305},"JYO","Knife, Ear",{"product_code":310,"device_name":311,"device_class":8,"k510_count":213},"JYJ","Gauge, Measuring",{"product_code":313,"device_name":314,"device_class":8,"k510_count":213},"JYL","Hook, Microsurgical Ear",{"product_code":316,"device_name":317,"device_class":8,"k510_count":213},"JZF","Tube, Ear Suction",{"product_code":319,"device_name":320,"device_class":8,"k510_count":213},"KAD","Elevator, Ent",{"product_code":322,"device_name":323,"device_class":8,"k510_count":213},"KTG","Knife, Ent",{"product_code":325,"device_name":326,"device_class":8,"k510_count":327},"JYM","Inserter, Myringotomy Tube",4,{"product_code":329,"device_name":330,"device_class":8,"k510_count":327},"JZB","Scissors, Ear",{"product_code":332,"device_name":333,"device_class":8,"k510_count":327},"KAC","Tube, Laryngectomy",{"product_code":335,"device_name":336,"device_class":8,"k510_count":327},"KBC","Saw, Nasal",{"product_code":338,"device_name":339,"device_class":8,"k510_count":340},"JYS","Perforator, Ear-Lobe",3,{"product_code":342,"device_name":343,"device_class":8,"k510_count":340},"KAR","Irrigator, Sinus",{"product_code":345,"device_name":346,"device_class":8,"k510_count":340},"KBD","Scissors, Nasal",{"product_code":348,"device_name":349,"device_class":8,"k510_count":340},"KBG","Trocar, Sinus",{"product_code":351,"device_name":352,"device_class":8,"k510_count":340},"KBN","Gag, Mouth",{"product_code":354,"device_name":355,"device_class":8,"k510_count":340},"KCD","Bougie, Esophageal, Ent",{"product_code":357,"device_name":358,"device_class":8,"k510_count":340},"KCF","Dilator, Esophageal, Ent",{"product_code":360,"device_name":361,"device_class":8,"k510_count":362},"EWQ","Saw, Surgical, Ent (Electric Or Pneumatic)",2,{"product_code":364,"device_name":365,"device_class":8,"k510_count":362},"JYQ","Loop, Wire",{"product_code":367,"device_name":368,"device_class":8,"k510_count":362},"JYR","Nipper, Malleus",{"product_code":370,"device_name":371,"device_class":8,"k510_count":362},"JYT","Pick, Microsurgical Ear",{"product_code":373,"device_name":374,"device_class":8,"k510_count":362},"JZD","Snare, Ear",{"product_code":376,"device_name":377,"device_class":8,"k510_count":362},"LJW","Tracheotome",{"product_code":379,"device_name":380,"device_class":8,"k510_count":211},"JYE","Chisel, Middle-Ear",{"product_code":382,"device_name":383,"device_class":8,"k510_count":211},"JYP","Knife, Myringotomy",{"product_code":385,"device_name":386,"device_class":8,"k510_count":211},"JYW","Press, Vein",{"product_code":388,"device_name":389,"device_class":8,"k510_count":211},"JYY","Rasp, Ear",{"product_code":391,"device_name":392,"device_class":8,"k510_count":211},"JYZ","Rod, Measuring Ear",{"product_code":394,"device_name":395,"device_class":8,"k510_count":211},"JZA","Rongeur, Mastoid",{"product_code":397,"device_name":398,"device_class":8,"k510_count":211},"JZE","Spoon, Ear",{"product_code":400,"device_name":401,"device_class":8,"k510_count":211},"KAB","Trocar, Laryngeal",{"product_code":403,"device_name":404,"device_class":8,"k510_count":211},"KAK","Probe, Ent",{"product_code":406,"device_name":407,"device_class":8,"k510_count":211},"KAP","Curette, Nasal",{"product_code":409,"device_name":410,"device_class":8,"k510_count":211},"KAS","Knife, Nasal",{"product_code":412,"device_name":413,"device_class":8,"k510_count":211},"KBF","Trephine, Sinus",{"product_code":415,"device_name":416,"device_class":8,"k510_count":211},"KBH","Adenotome",{"product_code":418,"device_name":419,"device_class":8,"k510_count":211},"KBJ","Curette, Adenoid",{"product_code":421,"device_name":422,"device_class":8,"k510_count":211},"KBL","Depressor, Metal Tongue, Surgical",{"product_code":424,"device_name":425,"device_class":8,"k510_count":211},"KBM","Dissector, Tonsil",{"product_code":427,"device_name":428,"device_class":8,"k510_count":211},"KBO","Guillotine, Tonsil",{"product_code":430,"device_name":431,"device_class":8,"k510_count":211},"KBQ","Knife, Tonsil",{"product_code":433,"device_name":434,"device_class":8,"k510_count":211},"KBW","Screw, Oral",{"product_code":436,"device_name":437,"device_class":8,"k510_count":211},"KBZ","Snare, Tonsil",{"product_code":439,"device_name":440,"device_class":8,"k510_count":211},"KCA","Tonsillectome",{"product_code":442,"device_name":443,"device_class":8,"k510_count":211},"KCB","Tube, Tonsil Suction",{"product_code":445,"device_name":446,"device_class":8,"k510_count":211},"KCG","Dilator, Tracheal",{"product_code":448,"device_name":449,"device_class":8,"k510_count":211},"KTE","Trocar, Ent",{"product_code":451,"device_name":452,"device_class":8,"k510_count":211},"MMO","Tray, Surgical, Ent",{"product_code":454,"device_name":455,"device_class":8,"k510_count":211},"QGK","Balloon, Nasal Airway",{"product_code":457,"device_name":458,"device_class":8,"k510_count":211},"SBS","Laryngeal Injection Set With Led Light",{"product_code":460,"device_name":461,"device_class":8,"k510_count":214},"JYF","Clamp, Ossicle Holding",{"product_code":463,"device_name":464,"device_class":8,"k510_count":214},"JYH","Excavator, Ear",{"product_code":466,"device_name":467,"device_class":8,"k510_count":214},"JYI","Gauge, Mastoid",{"product_code":469,"device_name":470,"device_class":8,"k510_count":214},"JYN","Inserter, Sacculotomy Tack",{"product_code":472,"device_name":473,"device_class":8,"k510_count":214},"JYX","Punch, Attic",{"product_code":475,"device_name":476,"device_class":8,"k510_count":214},"JZC","Searcher, Mastoid",{"product_code":478,"device_name":479,"device_class":8,"k510_count":214},"JZY","Knife, Laryngeal",{"product_code":481,"device_name":482,"device_class":8,"k510_count":214},"JZZ","Saw, Laryngeal",{"product_code":484,"device_name":485,"device_class":8,"k510_count":214},"KAA","Set, Laryngeal Injection",{"product_code":487,"device_name":488,"device_class":8,"k510_count":214},"KAH","Microrule, Ent",{"product_code":490,"device_name":491,"device_class":8,"k510_count":214},"KAJ","Mobilizer, Ent",{"product_code":493,"device_name":494,"device_class":8,"k510_count":214},"KAO","Curette, Ethmoid",{"product_code":496,"device_name":497,"device_class":8,"k510_count":214},"KAQ","Gouge, Nasal, Ent",{"product_code":499,"device_name":500,"device_class":8,"k510_count":214},"KAT","Perforator, Antrum",{"product_code":502,"device_name":503,"device_class":8,"k510_count":214},"KAW","Punch, Antrum",{"product_code":505,"device_name":506,"device_class":8,"k510_count":214},"KAX","Punch, Ethmoid",{"product_code":508,"device_name":509,"device_class":8,"k510_count":214},"KAY","Punch, Nasal",{"product_code":511,"device_name":512,"device_class":8,"k510_count":214},"KAZ","Rasp, Frontal-Sinus",{"product_code":514,"device_name":515,"device_class":8,"k510_count":214},"KBA","Rasp, Nasal",{"product_code":517,"device_name":518,"device_class":8,"k510_count":214},"KBB","Rongeur, Nasal",{"product_code":520,"device_name":521,"device_class":8,"k510_count":214},"KBE","Snare, Nasal",{"product_code":523,"device_name":524,"device_class":8,"k510_count":214},"KBK","Curette, Salpingeal",{"product_code":526,"device_name":527,"device_class":8,"k510_count":214},"KBP","Hook, Tonsil Suturing",{"product_code":529,"device_name":530,"device_class":8,"k510_count":214},"KBR","Needle, Tonsil Suturing",{"product_code":532,"device_name":533,"device_class":8,"k510_count":214},"KBS","Punch, Adenoid",{"product_code":535,"device_name":536,"device_class":8,"k510_count":214},"KBT","Punch, Tonsil",{"product_code":538,"device_name":539,"device_class":8,"k510_count":214},"KBX","Screw, Tonsil",{"product_code":541,"device_name":542,"device_class":8,"k510_count":214},"KCC","Bistoury, Tracheal",{"product_code":544,"device_name":545,"device_class":8,"k510_count":214},"KCH","Hook, Tracheal",{"product_code":547,"device_name":548,"device_class":8,"k510_count":214},"KCI","Trocar, Tracheal",{"product_code":550,"device_name":551,"device_class":8,"k510_count":214},"KTF","Punch, Ent",{"product_code":553,"device_name":554,"device_class":8,"k510_count":214},"NLB","Trocar, Tracheal, Laryngeal, Sinus, Reprocessed",{"product_code":556,"device_name":557,"device_class":8,"k510_count":214},"OGR","Ear, Nose, And Throat Surgical Tray",{"product_code":559,"device_name":560,"device_class":8,"k510_count":214},"OGU","Pierced Ear\u002FEntry Cleaning Tray",{"510k":562,"classification":563,"enforcement":564,"event":565,"pma":566,"warning_letter":567},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]