[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PZG":3},{"classification":4,"mappedDevices":66,"similarCandidates":67,"relatedClassifications":144,"syncDates":265},{"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":60,"updated_at":61,"recall_count":62,"latest_recall_date":63,"k510_count":64,"pma_count":64,"event_count":65},432,"PZG","Surgical Eye Tray","1","886.4350","OP","Ophthalmic","7","This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FGuidanceDocuments\u002Fucm080217.pdf.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":57,"device_class":8,"implant_flag":58,"product_code":6,"review_panel":10,"gmp_exempt_flag":58,"third_party_flag":58,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":57,"life_sustain_support_flag":58,"medical_specialty_description":11,"summary_malfunction_reporting":59},{"fei_number":17,"registration_number":47},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"3007329020","3002681132","3004911384","3009888344","3014257280","3015177648","3017857440","1929756","3013421458","3004111573","1643817","1211998","3008388245","1000117501","3013466775","3002616700","2242450","3013602181","1000512168","3001236905","3012733432","3010155661","3002902735","3009756153","1610287","3000215259","2083373","3002808441","3012539515",[18,20,21,22,23,24,25,26,27,48,28,29,30,32,49,50,34,35,51,38,52,53,39,54,42,41,55,56,44,46],"1423537","9680620","1061124","1121203","9616088","1226074","1650907","1644019","3006234743","","N","Ineligible","2026-08-18T05:52:47.660896+00:00","2026-08-18T22:05:38.961415+00:00",6,"2021-12-29",0,4,[],[68,77,84,92,99,107,114,123,131,138],{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},2264,"手術用タンプ","Ⅱ","32873000",0.454545,0.165289,0.500944,0.0163934,{"medical_device_id":78,"generic_name":79,"class_classification":71,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":76},2270,"再使用可能な外科処置キット","37547000",0.219512,0.177378,0.650128,{"medical_device_id":85,"generic_name":86,"class_classification":71,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},1813,"骨盤検査キット","34122000",0.025,0.124661,0.635523,0.016129,{"medical_device_id":93,"generic_name":94,"class_classification":95,"jmdn_code":96,"name_similarity":73,"definition_similarity":97,"vector_similarity":98,"score":91},3779,"外科用テープ","Ⅰ","70419000",0.0647059,0.534224,{"medical_device_id":100,"generic_name":101,"class_classification":71,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},2310,"再使用可能な吸引キット","37447000",0.0540541,0.183007,0.632978,0.015873,{"medical_device_id":108,"generic_name":109,"class_classification":95,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":106},4190,"手術用のこぎり","13448001",0.428571,0.161572,0.470307,{"medical_device_id":115,"generic_name":116,"class_classification":117,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":122},191,"単回使用クラスⅣ処置キット","Ⅳ","33961004",0.176471,0.167614,0.631908,0.015625,{"medical_device_id":124,"generic_name":125,"class_classification":126,"jmdn_code":127,"name_similarity":128,"definition_similarity":129,"vector_similarity":130,"score":122},514,"手術用メッシュ","Ⅲ","16048003",0.391304,0.151762,0.4809,{"medical_device_id":132,"generic_name":133,"class_classification":126,"jmdn_code":134,"name_similarity":64,"definition_similarity":135,"vector_similarity":136,"score":137},510,"創傷被覆・保護材キット","34059000",0.119403,0.62918,0.0153846,{"medical_device_id":139,"generic_name":140,"class_classification":71,"jmdn_code":141,"name_similarity":128,"definition_similarity":142,"vector_similarity":143,"score":137},2239,"手術用クリップ","37406000",0.119565,0.505113,[145,149,153,157,161,165,169,173,177,180,184,187,190,194,197,200,203,207,210,213,216,219,222,226,229,232,235,238,241,244,247,250,253,256,259,262],{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"HMX","Cannula, Ophthalmic",77,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"HNN","Knife, Ophthalmic",54,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"HNR","Forceps, Ophthalmic",44,{"product_code":158,"device_name":159,"device_class":8,"k510_count":160},"HNY","Cystotome",20,{"product_code":162,"device_name":163,"device_class":8,"k510_count":164},"HNF","Scissors, Ophthalmic",15,{"product_code":166,"device_name":167,"device_class":8,"k510_count":168},"HRH","Trephine, Manual, Ophthalmic",12,{"product_code":170,"device_name":171,"device_class":8,"k510_count":172},"HNC","Specula, Ophthalmic",11,{"product_code":174,"device_name":175,"device_class":8,"k510_count":176},"HNL","Probe, Lachrymal",10,{"product_code":178,"device_name":179,"device_class":8,"k510_count":176},"HNQ","Hook, Ophthalmic",{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"HNH","Ring, Ophthalmic (Flieringa)",7,{"product_code":185,"device_name":186,"device_class":8,"k510_count":183},"HOE","Caliper, Ophthalmic",{"product_code":188,"device_name":189,"device_class":8,"k510_count":62},"HND","Spatula, Ophthalmic",{"product_code":191,"device_name":192,"device_class":8,"k510_count":193},"HNJ","Punch, Corneo-Scleral",3,{"product_code":195,"device_name":196,"device_class":8,"k510_count":193},"HNW","Dilator, Lachrymal",{"product_code":198,"device_name":199,"device_class":8,"k510_count":193},"HOB","Clamp, Muscle, Ophthalmic",{"product_code":201,"device_name":202,"device_class":8,"k510_count":193},"HOD","Clamp, Eyelid, Ophthalmic",{"product_code":204,"device_name":205,"device_class":8,"k510_count":206},"HNA","Spud, Ophthalmic",2,{"product_code":208,"device_name":209,"device_class":8,"k510_count":206},"HNI","Retractor, Ophthalmic",{"product_code":211,"device_name":212,"device_class":8,"k510_count":206},"HNM","Needle, Ophthalmic Suturing",{"product_code":214,"device_name":215,"device_class":8,"k510_count":206},"HNX","Depressor, Orbital",{"product_code":217,"device_name":218,"device_class":8,"k510_count":206},"HNZ","Curette, Ophthalmic",{"product_code":220,"device_name":221,"device_class":8,"k510_count":206},"HOC","Clip, Iris Retractor",{"product_code":223,"device_name":224,"device_class":8,"k510_count":225},"HOF","Burr, Corneal, Manual",1,{"product_code":227,"device_name":228,"device_class":8,"k510_count":225},"NGY","Cannula, Trocar, Ophthalmic",{"product_code":230,"device_name":231,"device_class":8,"k510_count":64},"HMZ","Trabeculotome",{"product_code":233,"device_name":234,"device_class":8,"k510_count":64},"HNB","Spoon, Ophthalmic",{"product_code":236,"device_name":237,"device_class":8,"k510_count":64},"HNE","Snare, Enucleating",{"product_code":239,"device_name":240,"device_class":8,"k510_count":64},"HNG","Rongeur, Lachrymal Sac",{"product_code":242,"device_name":243,"device_class":8,"k510_count":64},"HNK","Probe, Trabeculotomy",{"product_code":245,"device_name":246,"device_class":8,"k510_count":64},"HNP","Introducer, Sphere",{"product_code":248,"device_name":249,"device_class":8,"k510_count":64},"HNS","Expressor",{"product_code":251,"device_name":252,"device_class":8,"k510_count":64},"HNT","Erisophake",{"product_code":254,"device_name":255,"device_class":8,"k510_count":64},"HOA","Compressor, Orbital",{"product_code":257,"device_name":258,"device_class":8,"k510_count":64},"MXY","Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal",{"product_code":260,"device_name":261,"device_class":8,"k510_count":64},"NLA","Knife, Ophthalmic, Reprocessed",{"product_code":263,"device_name":264,"device_class":8,"k510_count":64},"QDV","Iol Tray",{"510k":266,"classification":267,"enforcement":268,"event":269,"pma":270,"warning_letter":271},"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"]