EZD
- 产品代码
- EZD
- 器械名称
- Catheter, Straight
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.5130
- 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)
- 23 件
- 其中 Summary 已存档
- 21 份，可直接下载
- FDA 历史累计 510(k)
- 86 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)（23 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260737 | 2026-08-05 | Convatec | Cure Aqua Ready to Use Hydrophilic Intermittent Cat… | |
| K261658 | 2026-07-17 | Wellspect AB | LoFric Origo Pro Coudé | |
| K262045 | 2026-07-07 | Coloplast A.S. | Luja Soft | |
| K260394 | 2026-06-24 | Hangzhou Jimushi Meditech Co., Ltd. | Hydrophilic coated intermittent nalaton catheter for… | |
| K253295 | 2026-05-18 | Hollister Incorporated | Coude Sleeved IC; Coude Plus Sleeved IC | |
| K260999 | 2026-04-24 | Wellspect AB | LoFric Elle Pro | |
| K252943 | 2026-04-01 | Convatec Limited | GentleCath Air for Men; GentleCath Glide Intermitten… | |
| K260502 | 2026-03-12 | HR Healthcare | Liv Pre-lubricated Intermittent Catheter | |
| K251274 | 2026-01-29 | HR Healthcare | EZ-Protect Hydrophilic Closed System Intermittent Ca… | |
| K251178 | 2026-01-02 | Jamjoom Fullcare Corporation | Ready to use Nelaton Catheter | |
| K251468 | 2025-10-03 | Hollister Incorporated | Sleeved IC 3 Family Sleeved IC 3 SWT (name not final… | |
| K250659 | 2025-09-26 | Wellspect AB | LoFric Origo | |
| K250699 | 2025-07-01 | Convatec | Cure Twist Female 8 Catheter (T8); Cure Twist Female… | |
| K251116 | 2025-06-27 | Coloplast Corp. | Luja Coudé | |
| K243175 | 2025-06-26 | Chengdu Daxan Innovative Medical Tech.… | Disposable Intermittent Catheter (TPU Catheter) | FDA |
| K250270 | 2025-04-17 | Coloplast Corp. | Luja Set | |
| K242049 | 2024-11-26 | Coloplast Corp. | SureCath Set | |
| K241210 | 2024-11-21 | Coloplast Corp. | Luja Coude | |
| K241028 | 2024-07-26 | Coloplast | Luja female (20051); Luja female (20052); Luja femal… | |
| K233524 | 2024-05-03 | Hollister Incorporated | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Fina… | |
| K232665 | 2024-01-25 | Convatec | GentleCath Air for Women (CH10); GentleCath Air for … | |
| K230400 | 2023-11-08 | Convatec, Inc. | Cure Catheter Closed System; Cure Dextra Closed Syst… | |
| K233101 | 2023-10-26 | Coloplast Corp. | Luja Coude (20108 Male CH18 - large packaging) | FDA |
FDA 官方分类页： EZD
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。