KNW
- 产品代码
- KNW
- 器械名称
- Instrument, Biopsy
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.1075
- 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)
- 26 件
- 其中 Summary 已存档
- 23 份，可直接下载
- FDA 历史累计 510(k)
- 365 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)（26 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260517 | 2026-08-28 | Zhejiang Curaway Medical Technology Co… | Automatic Core Biopsy Instrument | |
| K262571 | 2026-08-14 | Bard Peripheral Vascular, Inc. | EnCor EnCompass Breast Biopsy and Tissue Removal Sy… | |
| K262792 | 2026-08-12 | Hologic, Inc. | Brevera Biopsy System with CorLumina Imaging Technol… | FDA |
| K260572 | 2026-08-04 | Medimetrix, LLC | Marrow Marxman | |
| K261196 | 2026-05-12 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed VeriEcto Automatic Biopsy Needles | |
| K260365 | 2026-03-04 | Devicor Medical Products, Inc. | Mammotome Prima MR Dual Vacuum-Assisted Breast Biop… | |
| K252795 | 2026-02-23 | Argon Medical Devices, Inc. | ZeniCore Automatic Biopsy Instrument (863212100 / … | |
| K252681 | 2025-12-12 | Bard Peripheral Vascular, Inc. | EnCor EnCompass Breast Biopsy and Tissue Removal Sy… | |
| K252183 | 2025-09-24 | Resitu Medical AB | Resitu Slider 09 (RESL09) | FDA |
| K243407 | 2025-07-29 | Forcyte Medical, LLC | Forcyte Autograft Harvest Kit | |
| K244018 | 2025-07-22 | Zhejiang Curaway Medical Technology Co… | Disposable Biopsy Needle | |
| K243296 | 2025-07-11 | Carbon (Shenzhen) Medical Device Co., … | Disposable Biopsy Needle | |
| K250032 | 2025-07-10 | Bard Peripheral Vascular, Inc. | Marquee Disposable Core Biopsy Instrument and Instr… | |
| K243886 | 2025-04-29 | Inrad, Inc. | ExpressCore Biopsy Device | |
| K243945 | 2025-04-24 | SurGenTec, LLC | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMA… | |
| K242128 | 2025-02-27 | Xaga Surgical | Forsvall biopsy needle system for prostate biopsy (F… | FDA |
| K242322 | 2025-01-24 | Zhejiang Curaway Medical Technology Co… | Bone Marrow Biopsy Needle | |
| K241793 | 2025-01-24 | Zhejiang Curaway Medical Technology Co… | Automatic Core Biopsy Instrument/ Semi-Automatic Cor… | |
| K242228 | 2025-01-10 | Triopsy Medical, Inc. | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN… | |
| K243095 | 2024-10-29 | Devicor Medical Products, Inc. | Mammotome AutoCore Single Insertion Core Biopsy Sys… | |
| K242029 | 2024-10-09 | H.S Hospital Service S.P.A | TRAP EASY | |
| K240664 | 2024-08-09 | SurGenTec, LLC | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMA… | |
| K233294 | 2024-06-18 | Itp Innovative Tomography Products Gmb… | Automatic Biopsy Needle BAM, Semi-Automatic Needle B… | |
| K233031 | 2024-01-17 | Canyon Medical, Inc. | M·Biopsy /SureCore Automatic Disposable Biopsy Needl… | |
| K230646 | 2023-11-29 | Uro-1 Medical, Inc. | SUREcore Prime Biopsy Instrument | |
| K233220 | 2023-10-27 | Senorx, Inc. | EnCor EnspireBreast Biopsy System (E4115, E4230); E… |
FDA 官方分类页： KNW
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。