HIH
- 产品代码
- HIH
- 器械名称
- Hysteroscope (And Accessories)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 884.1690
- FDA 专业组
- Obstetrics/Gynecology
- 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)
- 15 件
- 其中 Summary 已存档
- 12 份，可直接下载
- FDA 历史累计 510(k)
- 172 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)（15 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260984 | 2026-08-18 | Axora Medical, Inc. | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Re… | |
| K253020 | 2026-06-04 | American Medical Endoscopy, Inc. | Strauss Surgical Resection Instruments | — |
| K254050 | 2026-05-15 | Suzhou AcuVu Medical Technology Co., L… | Manual Tissue Removal Device | |
| K254251 | 2026-02-26 | Shanghai AnQing Medical Instrument Co.… | InnovexView (GC146-17, GC150-20, GC155-23) | FDA |
| K252793 | 2025-12-18 | Jiangsu Jiyuan Medical Technology Co.,… | ARMI® Endoscopic Video Image Processor (JY-MIP-3000)… | |
| K252012 | 2025-07-18 | Stryker Endoscopy | SPY Cystoscope/Hysteroscope | |
| K243382 | 2025-06-03 | Rz Medizintechnik GmbH | RZ Resectoscope System | |
| K240978 | 2024-08-16 | MacroLux Medical Technology Co., Ltd. | SeleneView® Single-Use Digital Hysteroscope (HC29, H… | |
| K241987 | 2024-08-02 | Guangzhou Red Pine Medical Instrument … | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | |
| K240401 | 2024-07-26 | Origyn Medical Technology (Hangzhou) C… | ClearVision Single Use Hysteroscope & Image Process… | |
| K231260 | 2024-03-05 | Suzhou AcuVu Medical Technology Co., L… | HTx Disposable Hysteroscope System | |
| K233635 | 2024-02-12 | Stryker Endoscopy | SPY Cystoscope/Hysteroscope | |
| K232003 | 2024-02-12 | Guangzhou Red Pine Medical Instrument … | Endoscopic Video Image Processor, Single-Use Video H… | |
| K233500 | 2023-11-30 | Caldera Medical, Inc. | Benesta Tissue Removal Device | — |
| K223885 | 2023-09-14 | Karl Storz Endoscopy America, Inc. | HOPKINS Telescopes |
FDA 官方分类页： HIH
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。