FBK
- 产品代码
- FBK
- 器械名称
- Endoscopic Injection Needle, Gastroenterology-Urology
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.1500
- FDA 专业组
- Gastroenterology, Urology
- 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)
- 89 件
FDA 分类定义
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
该代码近三年的 510(k)（11 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260262 | 2026-05-29 | Mirco-Tech (Nanjing) Co., Ltd. | Injection Needle 摘要 |
| K253598 | 2026-03-31 | Carbon Medical Technologies, Inc. | InjecSURE Injection System 摘要 |
| K252021 | 2025-12-02 | Changzhou New Med Micro-Medtech Co., L | Disposable Endoscopic Injection Needles 摘要 |
| K252247 | 2025-10-16 | Olympus Medical Systems Corporation | Injector Force Max Single Use Injector (NM-400L); In 摘要 |
| K241595 | 2025-02-27 | Veol Medical Technologies Pvt , Ltd. | EzVu Visual Vasopressor injector (EV-19) 摘要 |
| K240675 | 2024-10-04 | Promisemed Hangzhou Meditech Co., Ltd. | Endoscopic Injection Needles 摘要 |
| K241523 | 2024-08-27 | Laborie Medical Technologies, Corp. | injeTAK Adjustable Tip Needle (DIS199; DIS201) 摘要 |
| K232200 | 2024-04-12 | Ningbo Xinwell Medical Technology Co., | Disposable Injection Needles 摘要 |
| K232826 | 2024-03-08 | Steris | Articulator Injection Needle (00711807), Articulator 摘要 |
| K232442 | 2023-11-09 | Zhejiang Soudon Medical Technology Co. | Disposable Endoscope Injection Needles 摘要 |
| K230925 | 2023-09-27 | Alton (Shanghai) Medical Instruments C | Disposable Injection Needle AF series 摘要 |
FDA 官方分类页： FBK
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。