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KCT

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

产品代码
KCT
器械名称
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 880.6850
FDA 专业组
General Hospital
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
26 件
其中 Summary 已存档
19 份,可直接下载
FDA 历史累计 510(k)
280 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(26 件)

数据窗口为最近三年。最新一件:2026-06-18。

510(k) 号批准日期申请人器械名称摘要
K2531872026-06-18Mastel SurgicalSteriBest® Sterilization Tray SystemPDF
K2528542026-06-03Case Medical, Inc.SteriTite Container System with MediTray ProductsPDF
K2607262026-06-03Institut Straumann AGStraumann® ProClean™ Cassette (041.800 ; 041.801)PDF
K2537912026-02-26DePuy Mitek, Inc.PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™…PDF
K2516142026-02-06Dentsply Sirona, Inc.Stainless Steel Surgical KitsPDF
K2517562025-11-14Paragon Implant Mfg., LLCSterilization TraysPDF
K2434252025-07-22Talladium España, SLGuided DAS Surgical KitPDF
K2513002025-07-22Dentsply Sirona, Inc.Plastic Surgical KitsFDA
K2435892025-06-20Microaire Surgical Instruments, LLCPAL Sterilization CasePDF
K2427622025-05-13Aesculap, Inc.Aesculap Aicon® Series Container SystemPDF
K2500292025-05-01Innovative Sterilization TechnologiesONE TRAY® Sealed Sterilization Container SystemPDF
K2419272025-03-28Synthes GmbHSynthes Graphic Case & Tray SystemPDF
K2425642025-03-21Prismatik Dentalcraft, Inc.Autoclavable Cassette (Glidewell HT™ Implant Guided …FDA
K2420232025-02-19Implant Microdent System S.L.U.Microdent Sterilization CassettePDF
K2433172025-02-11Infinitum Eta, Ltd.NUVENTUS NV.C™ Surgical Cassette and TrayPDF
K2428342025-01-16Stryker InstrumentsSystem 9 Sterile Battery ContainerFDA
K2431282024-12-18SOADCO, S.L.Klockner KitsPDF
K2414922024-08-23JJGC Indústria e Comércio de Materiais…Guided Surgery Kit CasesPDF
K2408982024-07-31Case MedicalSteriTite rigid reusable sterilization container wit…FDA
K2410502024-07-16Crossroads Extremity SystemsCrossRoads Modular Tray SystemFDA
K2413782024-07-12S.I.N. - Sistema DE Implante Nacional …S.I.N. Instrument KitsFDA
K2312912024-06-03Richard Wolf Medical Instruments Corpo…Perforated BasketsPDF
K2335782024-03-22Bahadir USA, LLCBAHADIR STERILIZATION CONTAINERSPDF
K2311442024-01-16Dentsply SironaWashtraysPDF
K2332642023-12-22AnthogyrAnthogyr INTEGRAL Guided Surgery CassettesPDF
K2332222023-12-12Aygun Surgical Instruments Co., Inc.Aygün Sterilization Container Systems—

其中 19 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: KCT
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。