KCT
- 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)
- 280 件
该代码近三年的 510(k)（26 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253187 | 2026-06-18 | Mastel Surgical | SteriBest® Sterilization Tray System 摘要 |
| K252854 | 2026-06-03 | Case Medical, Inc. | SteriTite Container System with MediTray Products 摘要 |
| K260726 | 2026-06-03 | Institut Straumann AG | Straumann® ProClean Cassette (041.800 ; 041.801) 摘要 |
| K253791 | 2026-02-26 | DePuy Mitek, Inc. | PUREVUE Quick Connect Cannula System Tray; PUREVUE 摘要 |
| K251614 | 2026-02-06 | Dentsply Sirona, Inc. | Stainless Steel Surgical Kits 摘要 |
| K251756 | 2025-11-14 | Paragon Implant Mfg., LLC | Sterilization Trays 摘要 |
| K243425 | 2025-07-22 | Talladium España, SL | Guided DAS Surgical Kit 摘要 |
| K251300 | 2025-07-22 | Dentsply Sirona, Inc. | Plastic Surgical Kits 摘要 |
| K243589 | 2025-06-20 | Microaire Surgical Instruments, LLC | PAL Sterilization Case 摘要 |
| K242762 | 2025-05-13 | Aesculap, Inc. | Aesculap Aicon® Series Container System 摘要 |
| K250029 | 2025-05-01 | Innovative Sterilization Technologies | ONE TRAY® Sealed Sterilization Container System 摘要 |
| K241927 | 2025-03-28 | Synthes GmbH | Synthes Graphic Case & Tray System 摘要 |
| K242564 | 2025-03-21 | Prismatik Dentalcraft, Inc. | Autoclavable Cassette (Glidewell HT Implant Guided 摘要 |
| K242023 | 2025-02-19 | Implant Microdent System S.L.U. | Microdent Sterilization Cassette 摘要 |
| K243317 | 2025-02-11 | Infinitum Eta, Ltd. | NUVENTUS NV.C Surgical Cassette and Tray 摘要 |
| K242834 | 2025-01-16 | Stryker Instruments | System 9 Sterile Battery Container 摘要 |
| K243128 | 2024-12-18 | SOADCO, S.L. | Klockner Kits 摘要 |
| K241492 | 2024-08-23 | JJGC Indústria e Comércio de Materiais | Guided Surgery Kit Cases 摘要 |
| K240898 | 2024-07-31 | Case Medical | SteriTite rigid reusable sterilization container wit 摘要 |
| K241050 | 2024-07-16 | Crossroads Extremity Systems | CrossRoads Modular Tray System 摘要 |
| K241378 | 2024-07-12 | S.I.N. - Sistema DE Implante Nacional | S.I.N. Instrument Kits 摘要 |
| K231291 | 2024-06-03 | Richard Wolf Medical Instruments Corpo | Perforated Baskets 摘要 |
| K233578 | 2024-03-22 | Bahadir USA, LLC | BAHADIR STERILIZATION CONTAINERS 摘要 |
| K231144 | 2024-01-16 | Dentsply Sirona | Washtrays 摘要 |
| K233264 | 2023-12-22 | Anthogyr | Anthogyr INTEGRAL Guided Surgery Cassettes 摘要 |
| K233222 | 2023-12-12 | Aygun Surgical Instruments Co., Inc. | Aygün Sterilization Container Systems |
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。