KTI
- 产品代码
- KTI
- 器械名称
- Bronchoscope Accessory
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 874.4680
- FDA 专业组
- Ear, Nose, Throat
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 34 件
FDA 分类定义
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
该代码近三年的 510(k)（10 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261274 | 2026-07-24 | Cook Ireland, Ltd. | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Ne 摘要 |
| K251478 | 2026-04-16 | Finemedix Co., Ltd. | ClearTip TBNA Type 摘要 |
| K254040 | 2026-03-12 | Free Flow Medical, Inc. | LungFlow Basket Catheter 摘要 |
| K251402 | 2025-12-19 | Leadoptik, Inc. | LIA-1 Catheter (542-1) 摘要 |
| K252874 | 2025-10-08 | Serpex Medical, Inc. | Compass Steerable Needle with Adapters SRA-1-01 and 摘要 |
| K251664 | 2025-07-29 | Olympus Medical Systems Corporation | Single Use Aspiration Needle (NA-201SX-4021); Singl 摘要 |
| K250263 | 2025-03-31 | Olympus Medical Systems Corp. | Disposable Grasping Forceps FG-52D/FG-54D 摘要 |
| K241679 | 2025-03-04 | Alton (Shanghai) Medical Instruments C | Disposable Cytology Brush (AF series) 摘要 |
| K231818 | 2023-11-15 | M/S Meril Life Sciences Pvt. , Ltd. | METIC- Airway Balloon Catheter 摘要 |
| K230778 | 2023-09-25 | Praxis Medical, LLC | EndoCore 摘要 |
FDA 官方分类页： KTI
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。