EOB
- 产品代码
- EOB
- 器械名称
- Nasopharyngoscope (Flexible Or Rigid)
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 874.4760
- FDA 专业组
- Ear, Nose, Throat
- 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)
- 162 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)(9 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261544 | 2026-06-17 | Stryker Instruments | Hydro Irrigation System 摘要 |
| K254133 | 2026-05-14 | Optim, LLC | ENTity USB Videoscope System 摘要 |
| K253184 | 2026-03-25 | Zhuhai Wesee Meditech Co., Ltd. | Video Rhinolaryngoscope System (Disposable Video Rhi 摘要 |
| K252050 | 2026-03-20 | Olympus Medical Systems Corporation | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, 摘要 |
| K241731 | 2025-08-11 | Resnent, LLC | Outlook Surgical Versa One System (8900139) 摘要 |
| K243639 | 2025-06-05 | Grumpy Innovation, Inc. | Portare System (FA-001) 摘要 |
| K243380 | 2025-03-03 | Olympus Medical Systems Corporation | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMP 摘要 |
| K234096 | 2024-09-19 | Medicaltek Co., Ltd. | MonoStereo |
| K232435 | 2024-04-26 | Shenzhen HugeMed Medical Technical Dev | Rhinolaryngoscope system 摘要 |
FDA 官方分类页: EOB
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。