HIF
- 产品代码
- HIF
- 器械名称
- Insufflator, Laparoscopic
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 884.1730
- FDA 专业组
- Obstetrics/Gynecology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 13 件
- 其中 Summary 已存档
- 13 份，可直接下载
- FDA 历史累计 510(k)
- 179 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)（13 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260209 | 2026-08-19 | Karl Storz SE & CO. KG | ENDOFLATOR+; Smart Smoke Evacuation | |
| K252584 | 2026-06-25 | Weyo Surgical Technology , Ltd. | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, … | |
| K252318 | 2026-04-16 | Guangdong Optomedic Technologies, Inc. | Insufflator (OPTO-IFL1000) | |
| K250388 | 2025-09-22 | Karl Storz SE & CO. KG | ENDOFLATOR + | |
| K242772 | 2025-04-11 | SmartsurgN, Inc. | AirSurgN Insufflator (10030/AirSurgN) | |
| K243527 | 2025-01-13 | Olympus Medical Systems Corporation | High Flow Insufflation Unit (UHI-4) | |
| K242536 | 2024-10-15 | Tautona Group | TauTona Pneumoperitoneum Assist Device (TPAD) | |
| K232464 | 2024-05-02 | Freyja Healthcare, LLC | VereSee Optical Veres Needle System | |
| K232902 | 2024-05-02 | Palliare , Ltd. | EVA15 insufflator | |
| K233020 | 2024-01-12 | Tautona Group Research & Development, … | TauTona Pneumoperitoneum Assist Device (TPAD) | |
| K232401 | 2023-12-14 | Hangzhou Kangji Medical Instrument Co.… | Disposable Veress Needles | |
| K230239 | 2023-09-20 | Conmed Corporation | AirSeal iFS System; AirSeal dV Solution | |
| K231342 | 2023-09-20 | Guangdong Optomedic Technologies, Inc. | Insufflator (OPTO-IFL1000) |
FDA 官方分类页： HIF
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。