KNT
- 产品代码
- KNT
- 器械名称
- Tubes, Gastrointestinal (And Accessories)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.5980
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 16 件
- 其中 Summary 已存档
- 12 份，可直接下载
- FDA 历史累计 510(k)
- 651 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)（16 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261890 | 2026-08-14 | Boehringer Laboratories, LLC | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | |
| K253514 | 2026-07-10 | C.R. Bard, Inc. | Minnesota Four-Lumen Esophagogastric Tamponade Tube … | |
| K250389 | 2025-04-10 | Changzhou Xin Neng Yuan Medical Staple… | XNY Disposable Gastric Calibration Tube | FDA |
| K243228 | 2025-03-28 | Convatec | Flexi-Seal AIR (with ENFit Connector) | FDA |
| K242336 | 2025-01-17 | Amb Medtec | hygh-tec Drainage II | |
| K242901 | 2025-01-10 | Tools For Surgery, LLC | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube… | |
| K241169 | 2024-11-22 | Gravitas Medical, Inc. | Entarik NI Feeding Tube System | |
| K241185 | 2024-10-25 | Avanos Medical, Inc. | CORGRIP* SR NG/NI Tube Retention System | — |
| K240965 | 2024-06-06 | Avanos Medical, Inc. | CORTRAK* 2 Enteral Access System (20-0950) | — |
| K233591 | 2024-05-31 | Degania Silicone , Ltd. | Stylus | |
| K241039 | 2024-05-16 | Reshape Lifesciences | ReShape Calibration Tubes (B-2032, B-2036, B-2040); … | |
| K234033 | 2024-05-06 | Boehringer Laboratories, LLC | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (53… | |
| K240039 | 2024-04-17 | Hangzhou Primecare Medical Co., Ltd. | Enteral Feeding Sets | |
| K240069 | 2024-02-08 | Endolumik | Endolumik Gastric Calibration Tube M Series (EGCT36M… | |
| K234145 | 2024-01-26 | Boehringer Laboratories | ViSiGi 3D Gastric Sizing Tube | |
| K222846 | 2023-12-18 | Applied Medical Technology, Inc. | AMT G-Tube Balloon Gastrostomy Feeding Device |
FDA 官方分类页： KNT
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。